FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183527488
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-38602
Catalog number
BR46-38602
Device description
"SICKLE Knife, blunt, 7 1/2"""
Published
2024-07-17
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
KTGKnife, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTGKnife, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183527488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183527488008401835274888401835274880840183527488

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. 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
00840183531058BR Surgical, LLCBR Surgical, LLCKTG2026-07-17
00757770676521Bausch + LombBausch & Lomb IncorporatedKTG2026-06-22
00810220800300Adler Instrument CompanyAdler, Inc.KTG2026-06-02
00840343727550Gen2SURGIX MEDICAL LLCKTG2026-04-22
00840343727314GEN2SURGIX MEDICAL LLCKTG2026-04-16
00840343727321GEN2SURGIX MEDICAL LLCKTG2026-04-16
00757770429301Bausch + LombBausch & Lomb IncorporatedKTG2026-02-04
04250381870433SeparatorSpiggle & Theis Medizintechnik GmbHKTG2025-09-19
04250676723192Sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676735072KnifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676718600Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-12
04250676740595Teschner sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
04250676741790Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
00190776409371MillenniumAvalign Technologies, Inc.KTG2025-08-28
00190776409388MillenniumAvalign Technologies, Inc.KTG2025-08-28
00194613056377MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613056407MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613102609MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108700MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108762MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613118037MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613119621MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00757770422234Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00757770423699Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00190776406615MillenniumAvalign Technologies, Inc.KTG2025-07-23
00190776405694MillenniumAvalign Technologies, Inc.KTG2025-07-18
00190776397647MillenniumAvalign Technologies, Inc.KTG2025-05-16
00194613047504MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056353MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056360MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21