FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183513825
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR54-11615
Catalog number
BR54-11615
Device description
"JACKSON Trachea Hook, sharp, 6"""
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
KCHHook, Tracheal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCHHook, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183513825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183513825008401835138258401835138250840183513825

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable 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

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Primary DI, Brand, Company table
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00887482058640Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KCH2024-08-07
00190776390204MillenniumAvalign Technologies, Inc.KCH2024-05-31
00190776388997MillenniumAvalign Technologies, Inc.KCH2024-05-16
G043280300BEARBear-Ent, LLCKCH2024-04-25
00888515035676BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
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00888515035720BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035737BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035744BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035751BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
G586G93151250Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
G586G93151260Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
00190776045661AvalignAvalign Technologies, Inc.KCH2023-09-28
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00190776223892AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223939AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776321413MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321437MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321468MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321505MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321512MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
G2231336220Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKCH2023-08-23
00840319745212Hayden MedicalHayden Medical, Inc.KCH2023-03-14