-vixen-ivy Wolfe Janice Griffith - After Dark... Official
And somewhere in the static between skin and shadow, watches.
The club breathes low and slow. Bass like a second heartbeat. -Vixen-Ivy Wolfe Janice Griffith - After Dark...
Ivy leans close to Janice, lips barely brushing her ear. “You feel that?” And somewhere in the static between skin and shadow, watches
After dark, some stories don’t need words. sharp and electric
The neon hum of the city bleeds through rain-streaked windows. Three figures emerge from the velvet shadow—, sharp and electric, her gaze a dare; Janice Griffith , wildfire wrapped in silk, every move a promise; and the presence that binds them both: Vixen , the unseen force, the pulse in the dark.
Janice smiles—slow, dangerous. “The night’s just starting.”
Hello
We are company of medical device type II (sterelised needle) .Level of packagings are as following:
1 ) blister (direct packaging)
2) Dispenser 30 or 100 units
3) Shelf (about 1400 dispensers)
4) Shipper same as shelf (protective carton)
1)What is the alternative at blister packaging level , if we not indicate the manufacturer details : IFU, UDI etc is allow instead ?
2) same questions on Shipper level : what is the laternative ?
In Europe,US, Canada, turkie ?
3) What are the symbol that are mandatory according with packaging level?
Dear Nathalie,
the labeling on the sterile barrier system (SBS) – I assume in your case blister level, as these maintain the sterility of your device – is regulated either by the MDR (in Europe and also Türkiye) or by the recognized consensus standard ISO 11607-1 (EU, Türkiye, USA and Canada). In any case, the regulations require the manufacturer details directly on the SBS, there is no alternative.
Or are your devices not sold individually but only in the dispensers as the point of use? Then this dispenser could be considered as the outer protective packaging of your SBS and carry all required information.
The shipping packaging is only intended for transport and thus is not considered an additional packaging level, and as such is not required to fulfill any regulatory requirements. However, in certain cases (e.g. customs) a clear indication of the manufacturer is required to make the shipment traceable.
The information required on the packaging can be found in the MDR and 21 CFR part 801 as well as ISO 11607-1, the corresponding symbols in ISO 15223-1.
Let us know if we should discuss this in more detail in a short workshop, based specifically on your own device.
Kind regards
Christopher Seib