FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183505400
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
FG10-80001
Catalog number
FG10-80001
Device description
Splinter Removal Kit, (1) splinter forcep, (1) splinter remover
Published
2024-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXVGeneral Purpose Instrument Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183505400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183505400008401835054008401835054000840183505400

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true
Kit
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183529000BR Surgical, LLCBR900-5050-OLYSTZBR900-5050-OLYSTZ2024-11-07
00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23
00840183500238BR Surgical, LLCBR900-5050BR900-50502024-07-22
00840183501464BR Surgical, LLCBR900-5050-OLYBR900-5050-OLY2024-07-22
00840183501822BR Surgical, LLCBR900-3105BR900-31052024-07-22
00840183502072BR Surgical, LLCBR900-5050-ACMIBR900-5050-ACMI2024-07-22
00840183510244BR Surgical, LLCBR900-5050-ASBR900-5050-AS2024-07-22
00840183512149BR Surgical, LLCBR900-5050-ACOBR900-5050-ACO2024-07-22
00840183514891BR Surgical, LLCBR900-5050-WOLFBR900-5050-WOLF2024-07-22
00840183517861BR Surgical, LLCBR900-3103BR900-31032024-07-22
00840183522131BR Surgical, LLCBR900-5050-10BR900-5050-102024-07-22
00840183522957BR Surgical, LLCBR900-5050-OLY-6BR900-5050-OLY-62024-07-22
00840183523244BR Surgical, LLCBR900-5050-OLACBR900-5050-OLAC2024-07-22
00840183523312BR Surgical, LLCBR900-5050-PTXBR900-5050-PTX2024-07-22
00840183525491BR Surgical, LLCBR900-5050-7BR900-5050-72024-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956281660CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
50198956281668CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
10198956244580CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
50198956244588CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
10198956251915CARDINAL HEALTHCardinal Health 200, LLCPXV2025-11-04
10198956210370CARDINAL HEALTHCardinal Health 200, LLCPXV2025-10-03
10198956137479CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
10198956057500CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
00843356102741CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102758CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102765CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102772CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102789CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102796CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102744CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102751CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102768CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102775CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102782CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102799CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
10197106773284CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
50197106773282CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
00843356102819CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102826CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102833CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032440MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032457MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08