FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00857556008529
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-3192
Catalog number
BR900-3192
Device description
LED Premium Headlight, with Battery Pack, variable intensity control, with variable spot 20mm-110mm at 16", deluxe headband with crown, includes 2 rechargeable lithium ion battery and charger
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857556008529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857556008529008575560085298575560085290857556008529

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531065BR Surgical, LLCBR08-36111SCSBR08-36111SCS2025-09-29
00840183531089BR Surgical, LLCBR18-48273BR18-482732025-09-29
00840183531133BR Surgical, LLCBR12-32114BR12-321142025-09-29
00840183531171BR Surgical, LLCBR18-15003BR18-150032025-09-29
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057147028963LYNXUNIVET LOUPES SPAHPP2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPAHPP2026-03-02
00810186670214Enova IlluminationEnova Illumination, Inc.HPP2026-02-27
00860015454782RocotoRocoto Inc.HPP2026-02-26
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670139Enova IlluminationEnova Illumination, Inc.HPP2025-08-18
00194613122683MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
00194613122690MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
00840183529680BR Surgical, LLCBR Surgical, LLCHPP2025-07-16
00840183529970BR Surgical, LLCBR Surgical, LLCHPP2025-07-16
00860014100680AmimonRocoto Inc.HPP2025-06-24
00850061395016RONINRonin Surgical Corp.HPP2025-06-06
00860013851545C3QED, INC.HPP2025-05-21
00860013851552Centauri 2QED, INC.HPP2025-05-21
00817157020832AmimonAMIMON LTDHPP2025-04-03
00840277406941MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406958MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406965MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406972MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406989MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406996MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407009MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407016MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407023MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17