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ROLS Adapter Kit, for Kaps 12269

by Volk Optical Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811608019987 UDI-DIDate27 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
ROLS Adapter Kit, for Kaps
Generic Name
General-purpose surgical microscope
Model / Reference
12269
Primary DI / UDI-DI
00811608019987
FDA Product Code
FSO
GMDN Term
General-purpose surgical microscope
Device Class
Class I
Regulation Number
878.4700
GUDID distribution status
In Commercial Distribution

Other devices from Volk Optical Inc.

See all devices from Volk Optical Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No