FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183525217
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR40-05819
Catalog number
BR40-05819
Device description
CUSHING Nerve Hook, long-tip, 7"
Published
2024-03-07
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
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183525217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183525217008401835252178401835252170840183525217

GMDN Terms#

Term, Definition table
TermDefinition
Nerve/vessel retractorA hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. 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

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Primary DI, Brand, Company table
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04052536215522tezoUlrich GmbH & Co. KGGDG2026-03-16
00810158219328PRINCETONPrinceton Medical Group, Inc.GDG2026-03-12
00190776417826MillenniumAvalign Technologies, Inc.GDG2026-03-11
00190776417673MillenniumAvalign Technologies, Inc.GDG2026-03-04
00190776417512MillenniumAvalign Technologies, Inc.GDG2026-02-27
00190776416775MillenniumAvalign Technologies, Inc.GDG2026-02-20
00190776415761MillenniumAvalign Technologies, Inc.GDG2026-02-04
00190776415204MillenniumAvalign Technologies, Inc.GDG2026-01-27
00198506087431ELMED INCORPORATEDELMED INCORPORATEDGDG2026-01-07
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00810207782643Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782650Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782667Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
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