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
Rx
false
OTC
false
Sterile
false
Single use
false

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

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058179769InstrapacROBINSON HEALTHCARE LIMITEDHDJ2025-05-21
04049047003236GimmiGimmi GmbHHDJ2025-04-22
04049047003243GimmiGimmi GmbHHDJ2025-04-22
04049047003250GimmiGimmi GmbHHDJ2025-04-22
04049047003267GimmiGimmi GmbHHDJ2025-04-22
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 Surgical®SYMMETRY SURGICAL INC.HDJ2022-09-21
00887482049518Symmetry Surgical®SYMMETRY SURGICAL INC.HDJ2022-09-21
00887482078983Symmetry Surgical®SYMMETRY SURGICAL INC.HDJ2022-09-21
40889942674122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HDJ2022-08-04
00190660157326Ambler SurgicalAMBLER SURGICAL CORP.HDJ2021-01-04
00190660171940Ambler SurgicalAMBLER SURGICAL CORP.HDJ2021-01-04
04046826070908MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDJ2020-09-24
04046826070915MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDJ2020-09-24
04046826070946MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDJ2020-09-24
04046826070922MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDJ2020-09-24
04046826070939MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDJ2020-09-24
04038653042494AESCULAPAesculap AGHDJ2020-04-20
04038653022281AESCULAPAesculap AGHDJ2020-04-17
04038653022298AESCULAPAesculap AGHDJ2020-04-17
10885403045813V. MuellerCAREFUSION 2200, INCHDJ2020-04-15
00840314210456gSourceGSOURCE LLCHDJ2020-01-08
M7552946500gSourceGSOURCE LLCHDJ2020-01-08