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Custom Pack 08-PK106

by Advance Medical Designs, Inc.

Ref 08-PK106

Custom Pack 08-PK106 is a device classified as Class I in the EU and Class II in the US made by Advance Medical Designs, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 8483400008-PK106PM), cleared under FDA 510(k) K850959 on 9 Apr 1985 and listed in FDA GUDID since 21 Feb 2024 (UDI-DI 00848340002403), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K850959

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8483400008-PK106PM Basic UDI-DI 00848340002403UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848340002403 UDI-DI Date21 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK850959 Date9 Apr 1985DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8483400008-PK106PM registered 2 Nov 2026 Active
  • FDA 510(k) K850959 decided 9 Apr 1985 Active
  • FDA GUDID UDI-DI 00848340002403 listed 21 Feb 2024 Listed

Recalls

1 recall · FDA

    • Terminated Z-1036-04 FDA Unclassified (pre-2012) initiated 18 Jun 2004

    The product may come apart when excessive force is applied to the coupler.

Timeline

4 dated events

  1. Cleared FDA 510(k) K850959
  2. Recall initiated FDA recalls Z-1036-04
  3. Listed FDA GUDID 00848340002403
  4. Registered EUDAMED 8483400008-PK106PM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Custom Pack
Generic name
Medical equipment/instrument drape, single-use
Model / reference
08-PK106
Primary DI / UDI-DI
00848340002403
Basic UDI-DI
8483400008-PK106PM
510(k) Number
FDA product code
JAA
EMDN code
T030199 Covers, instruments and equipment - other
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00848340002403: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 00848340002403: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Medical equipment/instrument drape, single-use

Cleared under the same submission (K850959)

and 8 more cleared under K850959

Similar devices in this category

Other devices filed under COVERS, INSTRUMENTS AND EQUIPMENT - OTHER.

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)