FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183507435
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR08-36211
Catalog number
BR08-36211
Device description
"STEVENS Tenotomy Scissors, straight, blunt, 4 1/4"""
Published
2023-04-14
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183507435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183507435008401835074358401835074350840183507435

GMDN Terms#

Term, Definition table
TermDefinition
TenotomeA small, narrow-bladed knife mounted on a slender handle; usually used to cut a tendon. This GMDN code is sometimes applied to fine scissors, often adapted with a spring-like mechanism to keep the scissors open, used to cut tendons. 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
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
00840183531423BR Surgical, LLCBR10-18115ABR10-18115A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422202MillenniumAvalign Technologies, Inc.LRW2026-07-28
00198506092800ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093036ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093326ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093401ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
B382SD9037871020Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871030Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871090Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741050Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741100Surgical DirectSurgical Direct, Inc.LRW2026-07-28
00190776405915MillenniumAvalign Technologies, Inc.LRW2026-07-26
00190776422028MillenniumAvalign Technologies, Inc.LRW2026-07-24
00190776421908MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421922MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776403256MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403300MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403669MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776400392MillenniumAvalign Technologies, Inc.LRW2026-07-17
00840183531546BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531553BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
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00840183531614BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531645BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531706BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183532406BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
04058749007428NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749045383NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749048131NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749121131NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749121148NAFehling Instruments GmbH & Co. KGLRW2026-07-17