FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183510206
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR20-55405
Catalog number
BR20-55405
Device description
VARADY Phlebectomy Micro Extractor, 170mm
Published
2024-06-03
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
GAIStripper, Vein, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAIStripper, Vein, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183510206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183510206008401835102068401835102060840183510206

GMDN Terms#

Term, Definition table
TermDefinition
Vein stripper, reusableA hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a reusable device.

Sterilization Methods#

Method table
Method
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
Lot or batch
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

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Primary DI, Brand, Company table
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00190776393328MillenniumAvalign Technologies, Inc.GAI2025-05-06
00190776393762MillenniumAvalign Technologies, Inc.GAI2025-05-06
08403207004444Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004451Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004468Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
00840183505974BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510312BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183514204BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183517410BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
G586G91006920Novo SurgicalNOVO SURGICAL, INC.GAI2023-12-18
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00840319753835Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00840319753842Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00840319753859Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00190776334611MILLENNIUMAvalign Technologies, Inc.GAI2023-09-28
00842962109311HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842962109489HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842962109496HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842962109502HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842331186677Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-14
00842331186684Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-14
00842331186691Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-14
00842331138263Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-11