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Salvin Dental Specialties DRAPE-SPLIT-SHEET

by Salvin Dental Specialties, LLC

Listed FDA GUDID listing, no authorization on record

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 Number00841336114630 UDI-DI Date28 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-3079-2017 FDA Class II initiated 1 Jun 2017

    The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

  • 2 recalls, same reason

    • Terminated Z-2010-2018 FDA Class II initiated 11 Apr 2018 on shared 510(k) K964142
    • Terminated Z-1963-2018 FDA Class II initiated 11 Apr 2018 on shared 510(k) K964142

    Product sterility may be compromised due to unsealed packaging.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Salvin Dental Specialties
Generic Name
Patient surgical drape, single-use
Model / Ref / Catalog
DRAPE-SPLIT-SHEET
Primary DI / UDI-DI
00841336114630
510(k) Number
FDA Product Code
KKK, FYA
GMDN Term
Patient surgical drape, single-use
Device Class
Class I
Regulation Number
864.1850, 878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K964142)

Other devices from Salvin Dental Specialties, LLC

See all devices from Salvin Dental Specialties, LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (9)

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