FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183501525
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR68-43102
Catalog number
BR68-43102
Device description
Description McGIVNEY Hemorrhoidal Ligator Set: (1) Ligator and cone, (1) 100-piece latex-free O-rings, (1) grasping forceps
Published
2022-11-23
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
FHNLigator, Hemorrhoidal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183501525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183501525008401835015258401835015250840183501525

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligatorA hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. 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
00860014651113LHC Power Bander LHC Power Bander LLCFHN2026-03-03
16932503532850Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532867Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532874Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532881Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532898Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532904Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532911Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532935Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532942Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
08033638801727Self-Suction-LEMSAPI MED SPAFHN2026-02-06
16932503532928Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-01-30
06923646508645Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508652Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508669Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508676Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508683Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508690Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508706Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508713Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508720Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508744Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508638Ligation DeviceLeo Medical Co., Ltd.FHN2025-12-18
06923646508737Ligation DeviceLeo Medical Co., Ltd.FHN2025-12-18
00860006350277Snyder HemBandWILBUR HILL LLCFHN2025-09-04
00868852000414EZ Band Hemorrhoidal LigatorWILBUR HILL LLCFHN2025-09-04
00194613121907MSI Precision Specialty InstrumentsMed Saver, Inc.FHN2025-08-01
00190776401757MillenniumAvalign Technologies, Inc.FHN2025-06-12
00858276007410In-SightMicro-tech UsaFHN2025-03-03
00840183529307BR Surgical, LLCBR Surgical, LLCFHN2025-01-03