FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183514884
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR20-55406
Catalog number
BR20-55406
Device description
VARADY Phlebectomy Mini Extractor, 170mm
Published
2022-11-22
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
NJZExtractor, Vein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJZExtractor, VeinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183514884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183514884008401835148848401835148840840183514884

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183512040BR Surgical, LLCBR44-19117BR44-191172024-06-03
00840183531430BR Surgical, LLCBR32-47202BR32-472022026-07-22
00840183531980BR Surgical, LLCBR24-67215BR24-672152026-07-22
00840183532017BR Surgical, LLCBR32-47193BR32-471932026-07-22
00840183532024BR Surgical, LLCBR32-47194BR32-471942026-07-22
00840183532031BR Surgical, LLCBR32-47195BR32-471952026-07-22
00840183532093BR Surgical, LLCBR32-38015BR32-380152026-07-22
00840183532154BR Surgical, LLCBR32-24723BR32-247232026-07-22
00840183532161BR Surgical, LLCBR32-23723BR32-237232026-07-22
00840183532178BR Surgical, LLCBR32-23022BR32-230222026-07-22
00840183531232BR Surgical, LLCBR18-21001BR18-210012026-07-21
00840183531720BR Surgical, LLCBR24-25427BR24-254272026-07-21
00840183532185BR Surgical, LLCBR18-68528BR18-685282026-07-21
00840183532192BR Surgical, LLCBR18-68516BR18-685162026-07-21
00840183532222BR Surgical, LLCBR18-27003BR18-270032026-07-21
00840183532239BR Surgical, LLCBR18-27004BR18-270042026-07-21
00840183532383BR Surgical, LLCBR20-10611BR20-106112026-07-21
00840183532475BR Surgical, LLCBR24-19018BR24-190182026-07-21
00840183532499BR Surgical, LLCBR24-32026BR24-320262026-07-21
00840183532628BR Surgical, LLCBR18-30004BR18-300042026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482073346Symmetry SaalfeldASPEN SURGICAL PRODUCTS, INC.NJZ2024-08-20
07898506835720QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835737QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835744QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835751QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835768QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835775QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835782QuinelatoSchobell Industrial LtdaNJZ2023-01-11
B97450473207Vein HookDR.FRIGZ INTERNATIONAL(PVT)LTD,NJZ2022-11-21
00616784420516Venom Extractor KitsDynarex CorporationNJZ2020-11-02