FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183532161
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR32-23723
Catalog number
BR32-23723
Device description
STILLE RUSKIN Bone Rongeur, 9"
Published
2026-07-22
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183532161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183532161008401835321618401835321610840183532161

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
00840183512040BR Surgical, LLCBR44-19117BR44-191172024-06-03
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
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
00190776437367MillenniumAvalign Technologies, Inc.HTX2026-11-02
00190776437466MillenniumAvalign Technologies, Inc.HTX2026-11-02
B382SD914763020Surgical DirectSurgical Direct, Inc.HTX2026-10-30
B382SD914763010Surgical DirectSurgical Direct, Inc.HTX2026-10-28
00724995267919Snowden-PencerSTERIS Deutschland GmbHHTX2026-10-27
00724995312992V. MuellerSTERIS Deutschland GmbHHTX2026-10-27
10840642182149Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182156Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182163Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
00840217909327Wiggins MedicalEBNER MEDICAL, LLCHTX2024-12-09
00840217908924Wiggins MedicalEBNER MEDICAL, LLCHTX2024-03-21
00840217908658Wiggins MedicalEBNER MEDICAL, LLCHTX2024-01-25
B382SD9212021100Surgical DirectSurgical Direct, Inc.HTX2022-12-01
B382SD921226190Surgical DirectSurgical Direct, Inc.HTX2022-12-01