FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183522834
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR44-32570
Catalog number
BR44-32570
Device description
BELLUCCI Micro Scissors, curved right, 7.0mm, 3 1/4"
Published
2024-02-21
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
JZBScissors, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZBScissors, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183522834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183522834008401835228348401835228340840183522834

GMDN Terms#

Term, Definition table
TermDefinition
Ear scissors, reusableA long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.

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
00840183531065BR Surgical, LLCBR08-36111SCSBR08-36111SCS2025-09-29
00840183531089BR Surgical, LLCBR18-48273BR18-482732025-09-29
00840183531133BR Surgical, LLCBR12-32114BR12-321142025-09-29
00840183531171BR Surgical, LLCBR18-15003BR18-150032025-09-29
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811114808INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-03
09348811114839INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-01
09348811114976INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-01
09348811114815INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114822INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114853INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114860INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115003INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115041INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811172129INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115027INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
09348811172136INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
04250381854136Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854143Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854150Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676731920Reference instrumentSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745682ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745705ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745736ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-24
04250381854105Shea-Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676708915Scissors model BonnSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676744913Stapes scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676744920Stapes scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746207Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746214Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746221Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746238Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746245Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746269Shea-Bellucci scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746276Shea-Bellucci scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08