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Colorado Therapeutics Xenograft Implant XI-S+

by Colorado Therapeutics, LLC 12 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868623000360 UDI-DI Date5 Mar 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Colorado Therapeutics Xenograft Implant
Generic Name
Abdominal hernia surgical mesh, collagen, antimicrobial
Model / Ref / Catalog
XI-S+, XI0404-S+
Primary DI / UDI-DI
00868623000360
510(k) Number
FDA Product Code
FTM, OXK
GMDN Term
Abdominal hernia surgical mesh, collagen, antimicrobial
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Height — 4 Centimeter
Length — 4 Centimeter

Related devices

Category: Abdominal hernia surgical mesh, collagen, antimicrobial

Cleared under the same submission (K172937)

Other devices from Colorado Therapeutics, LLC

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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