Device
LMP F/LEMPERT-STORZ HEADLIGHTS
Manufacturer
Bausch & Lomb Incorporated
Model: N1009 Catalog: N1009 DI: 00757770419067 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
LMP F/LEMPERT-STORZ HEADLIGHTS
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: ad91e796-98c3-4496-a774-0cfec8765666
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: 00757770419067
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46807
Name: Head-worn lamp
Definition:
An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.
FDA Product Codes
HBI
Illuminator, Fiberoptic, Surgical Field