FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183523008
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR66-17508
Catalog number
BR66-17508
Device description
"STOCKMANN Penile Clamp, 3"""
Published
2024-06-10
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
FHAClamp, Penile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHAClamp, PenileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183523008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183523008008401835230088401835230080840183523008

GMDN Terms#

Term, Definition table
TermDefinition
Surgical penile clampA manual surgical instrument with two blades that are joined at their midpoint, or made of a single alpha-shaped part, intended to stop blood flow to the penis. This is a single-use 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613105082MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-08-01
04049047064947GimmiGimmi GmbHFHA2025-05-20
00194613031305MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613103484MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613106959MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613111113MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613061531MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2024-08-15
00887482075333Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.FHA2024-08-15
04049197264655RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFHA2024-06-28
04049197264662RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFHA2024-06-28
00653599002179KindKlampARGENTUM MEDICAL, LLCFHA2024-02-07
G586UR96208880Novo SurgicalNOVO SURGICAL, INC.FHA2023-12-18
00842962125977HNM MEDICALHNM STAINLESS, LLC.FHA2023-04-12
B974ZC1100PENIS CLAMPDR.FRIGZ INTERNATIONAL(PVT)LTD,FHA2022-11-21
08800064400004Jeato Incontinence ClampJeato Med. CO., Ltd.FHA2022-11-14
08800064400103Jeato 7 Incontinence Clamp Jeato Med. CO., Ltd.FHA2022-11-14
00842331127403Novo Surgical Inc. NOVO SURGICAL, INC.FHA2022-11-09
00887482076101Symmetry VasASPEN SURGICAL PRODUCTS, INC.FHA2022-09-21
00887482076194Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.FHA2022-09-21
00653599001660KindKlampARGENTUM MEDICAL, LLCFHA2021-09-20
00190660018443Ambler SurgicalAMBLER SURGICAL CORP.FHA2021-01-04
04046826062989MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFHA2020-09-24
04046826062996MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFHA2020-09-24
00801741049002Penile ClampC. R. Bard, Inc.FHA2020-09-22
00801741050961Penile ClampC. R. Bard, Inc.FHA2020-09-22
00801741072741Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
00801741072758Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
00801741072765Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
04038653039326AESCULAPAesculap AGFHA2020-04-20
00653599000007KindKlampARGENTUM MEDICAL, LLCFHA2020-01-22