FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183505165
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR08-55010
Catalog number
BR08-55010
Device description
"Umbilical Scissors, USA-model, delicate, 4 1/8"""
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
HDJScissors, Umbilical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDJScissors, UmbilicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183505165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183505165008401835051658401835051650840183505165

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord scissors, reusableA hand-held manual surgical instrument designed specifically to cut the umbilical cord after birth. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is metallic and is available in various designs and sizes; the blades can have a variety of sizes and designs, e.g., curved, acutely angled at the tip, or have flat opposing moon shapes, and may be serrated. 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

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Primary DI, Brand, Company table
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04049047003243GimmiGimmi GmbHHDJ2025-04-22
04049047003250GimmiGimmi GmbHHDJ2025-04-22
04049047003267GimmiGimmi GmbHHDJ2025-04-22
10885632431371MedichoiceOWENS & MINOR DISTRIBUTION, INC.HDJ2024-11-22
20885632431378MedichoiceOWENS & MINOR DISTRIBUTION, INC.HDJ2024-11-22
G586OB6473470Novo SurgicalNOVO SURGICAL, INC.HDJ2023-12-18
G586OB96473470Novo SurgicalNOVO SURGICAL, INC.HDJ2023-12-18
07898506815807QuinelatoSchobell Industrial LtdaHDJ2023-07-06
00190776376758AvalignAvalign Technologies, Inc.HDJ2023-06-23
G25002055100USA Umbilical Cord ScissorsN S SURGICAL COMPANYHDJ2023-03-18
00842331181757Novo Surgical Inc. NOVO SURGICAL, INC.HDJ2022-11-14
00842331144448Novo Surgical Inc. NOVO SURGICAL, INC.HDJ2022-11-11
00887482024164Symmetry BuschASPEN SURGICAL PRODUCTS, INC.HDJ2022-09-21
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00887482078983Symmetry BuschASPEN SURGICAL PRODUCTS, INC.HDJ2022-09-21
10889942674121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HDJ2022-08-04
40889942674122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HDJ2022-08-04
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