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PRS Series PRS4001A

by ScienceMedic Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number08800034446957 UDI-DI Date1 Aug 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PRS Series
Generic Name
Surgical saw blade, sagittal, single-use
Model / Reference
PRS4001A
Primary DI / UDI-DI
08800034446957
FDA Product Code
GFA
GMDN Term
Surgical saw blade, sagittal, single-use
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical saw blade, sagittal, single-use

Other devices from ScienceMedic Co., Ltd.

Properties

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

Other properties (9)

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