FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183500085
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-1101
Catalog number
BR900-1101
Device description
Endoscopic Video Camera, 1CCD, including camera head and coupler, with Built-In USB Image Capture System
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
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183500085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183500085008401835000858401835000850840183500085

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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
true
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
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00818089022437RadianceNds Surgical Imaging LLCKQM2026-02-10
08800025400692EZ SHOT SEGOOD DOCTORS CO., LTD.KQM2026-01-15
05415334050020BarcoBarco NVKQM2025-12-22
05415334050013BarcoBarco NVKQM2025-12-01
00819761023032Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-25
00819761023049Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-24
00860012447107EclipseInnovations Lightx IncKQM2025-11-12
00724995245061HexaVueBLACK DIAMOND VIDEO, INC.KQM2025-10-17
00810000890712FSNFORESEESON CUSTOM DISPLAYS, INC.KQM2025-09-15
04548736170698SONYSONY CORPORATIONKQM2025-09-12
04548736170711SONYSONY CORPORATIONKQM2025-09-12
07613327661194In-Light CameraSTRYKER COMMUNICATIONS INC.KQM2025-08-27
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
04995047069867CuratOREIZO CORPORATIONKQM2025-07-18
04995047070320CuratOREIZO CORPORATIONKQM2025-07-18
00840183530402BR Surgical, LLCBR Surgical, LLCKQM2025-07-16
20618125114669SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170728SONYSONY CORPORATIONKQM2025-07-08
04548736170742SONYSONY CORPORATIONKQM2025-07-08
06972039971085MOPTIMShenzhen CERTAINN Technology Co., Ltd.KQM2025-06-30
00860014100642AmimonRocoto Inc.KQM2025-06-24
00860014100659AmimonRocoto Inc.KQM2025-06-24
05415334051133SterisBarco NVKQM2025-06-05
04548736167117SONYSONY CORPORATIONKQM2025-05-30
04548736167124SONYSONY CORPORATIONKQM2025-05-30