FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183521844
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-130550
Catalog number
BR46-130550
Device description
Universal T-Tube Inserter, stainless steel shaft, with T-Tube loading device
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
JYMInserter, Myringotomy Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYMInserter, Myringotomy TubeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183521844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183521844008401835218448401835218440840183521844

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tube inserter, reusableA hand-held device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as a myringotomy tube, grommet or an aural vent tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10381780391333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391340Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856011Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856061Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
00681490038263N/AMEDTRONIC XOMED, INC.JYM2017-09-10
00681490038270N/AMEDTRONIC XOMED, INC.JYM2017-09-10