FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183515966
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR06-12435
Catalog number
BR06-12435
Device description
Myringotomy Knife/Blade w/Handle, sterile, spear tip, angled, 5/box
Published
2023-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYPKnife, Myringotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYPKnife, MyringotomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183515966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183515966008401835159668401835159660840183515966

GMDN Terms#

Term, Definition table
TermDefinition
Tympanotomy knife, single-useA hand-held, manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
B382SD920661200Surgical DirectSurgical Direct, Inc.JYP2026-07-29
00850083275792Intrace USAPILOTIS TECH LLCJYP2026-07-03
09421901970499Adept Medical Myringotomy KnifeADEPT MEDICAL LIMITEDJYP2024-03-20
G586E7213700Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
G586E7213780Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
00840183515973BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00842331167089Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-13
00842331148354Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-12
04046826103194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
04046826103200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
M6333814021ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633301705HH0JEDMEDJEDMED INSTRUMENT COMPANYJYP2020-09-01
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
04038653176366AESCULAPAesculap AGJYP2020-04-22
05060180259037EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180259068EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180254988EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180255022EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
10381780082514Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
10381780084440Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
05060180252809EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252816EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252823EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252830EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252847EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252854EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252861EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252878EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252885EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11