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EVA Cartridge with 0.5 L Collection Bag 8100.CAR01

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717872019178 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2252-2021 FDA Class II initiated 21 May 2019

    Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EVA Cartridge with 0.5 L Collection Bag
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
8100.CAR01
Primary DI / UDI-DI
08717872019178
510(k) Number
FDA Product Code
HQC, HQE
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Class
Class II
Regulation Number
886.4670, 886.4150
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K190875)

Show all (12)

Other devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

See all devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No