FDA.report

BR Surgical, LLC

Primary DI
00840183515928
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR98-50425
Catalog number
BR98-50425
Device description
SCHROEDER-BRAUN Tenaculum Forceps, straight, single-use, 9 3/4", 10 per box
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PUATenaculum, Uterine, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUATenaculum, Uterine, ExemptObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183515928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183515928008401835159288401835159280840183515928

GMDN Terms

TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.

Sterilization Methods

Method

Contacts

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
05010058178328InstrapacROBINSON HEALTHCARE LIMITEDPUA2025-05-21
05010058179578InstrapacROBINSON HEALTHCARE LIMITEDPUA2025-05-21
00840183518202BR Surgical, LLCBR Surgical, LLCPUA2024-07-23
00840319748527Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319748534Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749715Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749722Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749739Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749746Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749753Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749760Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749777Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749784Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749814Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749821Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749838Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749845Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749852Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319750544Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319750551Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319752661Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319752678Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319733325Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733387Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733394Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733400Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733417Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733424Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733431Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733448Hayden MedicalHayden Medical, Inc.PUA2022-09-12