FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183513856
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR72-18709
Catalog number
BR72-18709
Device description
COLLIN Umbilical Cord Clamp, 3 1/2"
Published
2024-07-22
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
HFWClamp, Umbilical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFWClamp, UmbilicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183513856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183513856008401835138568401835138560840183513856

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord clamp, reusableA hand-held manual surgical instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating (e.g., with a clip) the cord, and is intended to enable aseptic haemostasis. The design may incorporate features such as serrations on the contact area and/or a security lock. This is a reusable device after appropriate disinfection/sterilization.

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
30885632431368MedichoiceOWENS & MINOR DISTRIBUTION, INC.HFW2024-10-30
00840113231508Double-Grip Umbilical Cord ClampASPEN SURGICAL PRODUCTS, INC.HFW2023-02-27
10840113231512Double-Grip Umbilical Cord ClampASPEN SURGICAL PRODUCTS, INC.HFW2023-02-27
10840113231529Double-Grip Umbilical Cord ClampASPEN SURGICAL PRODUCTS, INC.HFW2023-02-27
20809160306083HalyardAVID MEDICAL, INC.HFW2020-12-10
40080196493402MEDLINEMEDLINE INDUSTRIES, INC.HFW2020-05-18
10767056094212MABIS DMID-M-S HOLDINGS, INC.HFW2020-02-17
50653160021382CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHFW2017-03-03
50653160010614CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHFW2016-11-30
10767056094113MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767056094236MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767056113845MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767056113852MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767506094212MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
20849233013036Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01
10849233018102Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01