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Universal Arm with Table Clamp 516-828

by Sontec Instruments, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 NumberB0995168280 UDI-DI Date26 Aug 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Universal Arm with Table Clamp
Generic Name
Externally-anchored laparoscopic retractor
Model / Reference
516-828
Primary DI / UDI-DI
B0995168280
510(k) Number
FDA Product Code
GCJ
GMDN Term
Externally-anchored laparoscopic retractor
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K152400)

Show all (12)

Other devices from Sontec Instruments, Inc.

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Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No
  • Manufacturing Date: No