FDA.report

BR Surgical, LLC

Primary DI
00840183501136
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-3100
Catalog number
BR900-3100
Device description
Fiberoptic Headlight w/ 3.5mm bifurcated 9-foot cable, 20mm-110mm spot size, & deluxe headband, Wolf fitting
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FCTHeadlight, Fiberoptic Focusing

Product Code Classifications

CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183501136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183501136008401835011368401835011360840183501136

GMDN Terms

TermDefinition
Head-worn fibreoptic lightA fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.

Sterilization Methods

Method

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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