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
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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05010058079762InstrapacROBINSON HEALTHCARE LIMITEDHDJ2025-05-21
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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
00190660157326Ambler SurgicalAMBLER SURGICAL CORP.HDJ2021-01-04
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