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XLR8/XLR8+ Port - Unsterile XP-1013-UNS

by Genadyne Biotechnologies Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00849405002659 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
XLR8/XLR8+ Port - Unsterile
Generic Name
Irrigation negative-pressure wound therapy unit
Model / Ref / Catalog
XP-1013-UNS
Primary DI / UDI-DI
00849405002659
510(k) Number
FDA Product Code
OMP
GMDN Term
Irrigation negative-pressure wound therapy unit
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K143726)

Other devices from Genadyne Biotechnologies Inc.

See all devices from Genadyne Biotechnologies Inc. →

Properties

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

Other properties (8)

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