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HEINE - BETA R HANDLE x-007.99.376

by Sontec Instruments, Inc. 2 variants

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 NumberB099X007993760 UDI-DI Date8 Aug 2017ListedStatusListed 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  • Withdrawn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
Heine - Beta R Handle
Generic Name
Indirect binocular ophthalmoscope
Model / Reference
x-007.99.376
Primary DI / UDI-DI
B099X007993760
510(k) Number
FDA Product Code
HLJ
GMDN Term
Indirect binocular ophthalmoscope
Device Class
Class II
Regulation Number
886.1570
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Dry Heat Sterilization

Related devices

Cleared under the same submission (K142486)

Show all (12)

Other devices from Sontec Instruments, Inc.

See all devices from Sontec Instruments, Inc. →

Properties

  • Prescription Use

Other properties (13)

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