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Single Use Flexible Video Ureteroscope PU631A-S

by Zhuhai Pusen Medical Technology Co, Ltd

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 Number06971176282948 UDI-DI Date13 Jan 2026ListedStatusListed 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  • Withdrawn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
Single Use Flexible Video Ureteroscope
Generic Name
Flexible video ureteroscope, single-use
Model / Reference
PU631A-S
Primary DI / UDI-DI
06971176282948
510(k) Number
FDA Product Code
FGB, FED
GMDN Term
Flexible video ureteroscope, single-use
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K233778)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No