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AVID TruCustom SETA003-01_0001

by Avid Medical, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10809160073568 UDI-DIDate9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
AVID TruCustom
Generic Name
General surgical procedure kit, medicated
Model / Ref / Catalog
SETA003-01_0001, SETA003-01
Primary DI / UDI-DI
10809160073568
FDA Product Code
LRO
GMDN Term
General surgical procedure kit, medicated
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

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