Device
LARYN MIR W/O HDL SZ1
Manufacturer
Bausch & Lomb Incorporated
Model: N77101 Catalog: N77101 DI: 00757770426027 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
LARYN MIR W/O HDL SZ1
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 2a4932dc-6827-4763-a03b-16d6fc376011
Distribution Status: In Commercial Distribution
DUNS Number: 196603781
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00757770426027
Type: Primary
Issuing Agency: GS1
GMDN
Code: 33431
Name: Laryngeal mirror, reusable
Definition:
A hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. This is a reusable device.
FDA Product Codes
KAI
Mirror, Ent