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Liofilchem Antibiotic Disc Sulopenem SPM 2 µg

by Liofilchem, Inc. 2 variants

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 Number08058951161310 UDI-DI Date3 Nov 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  • Withdrawn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
Liofilchem Antibiotic Disc
Generic Name
Antibacterial susceptibility testing disc IVD
Model / Reference
Sulopenem SPM 2 µg
Primary DI / UDI-DI
08058951161310
510(k) Number
FDA Product Code
JWY
GMDN Term
Antibacterial susceptibility testing disc IVD
Device Class
Class II
Regulation Number
866.1640
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251879)

Other devices from Liofilchem, Inc.

See all devices from Liofilchem, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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