FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183506049
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-42516
Catalog number
BR46-42516
Device description
"JOSEPH Periosteal Elevator, strong curve 6.5 mm blade, 6"""
Published
2024-06-03
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
KADElevator, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183506049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183506049008401835060498401835060490840183506049

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183529000BR Surgical, LLCBR900-5050-OLYSTZBR900-5050-OLYSTZ2024-11-07
00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23
00840183500238BR Surgical, LLCBR900-5050BR900-50502024-07-22
00840183501464BR Surgical, LLCBR900-5050-OLYBR900-5050-OLY2024-07-22
00840183501822BR Surgical, LLCBR900-3105BR900-31052024-07-22
00840183502072BR Surgical, LLCBR900-5050-ACMIBR900-5050-ACMI2024-07-22
00840183510244BR Surgical, LLCBR900-5050-ASBR900-5050-AS2024-07-22
00840183512149BR Surgical, LLCBR900-5050-ACOBR900-5050-ACO2024-07-22
00840183514891BR Surgical, LLCBR900-5050-WOLFBR900-5050-WOLF2024-07-22
00840183517861BR Surgical, LLCBR900-3103BR900-31032024-07-22
00840183522131BR Surgical, LLCBR900-5050-10BR900-5050-102024-07-22
00840183522957BR Surgical, LLCBR900-5050-OLY-6BR900-5050-OLY-62024-07-22
00840183523244BR Surgical, LLCBR900-5050-OLACBR900-5050-OLAC2024-07-22
00840183523312BR Surgical, LLCBR900-5050-PTXBR900-5050-PTX2024-07-22
00840183525491BR Surgical, LLCBR900-5050-7BR900-5050-72024-07-22
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

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Primary DI, Brand, Company table
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00757770683567Bausch + LombBausch & Lomb IncorporatedKAD2026-05-11
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09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
04046826112790MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAD2026-03-04
00190776415945MillenniumAvalign Technologies, Inc.KAD2026-02-06
00757770425143Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
00757770636822Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
09348811101587INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-28
00810207783039Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783046Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783053Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
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00810207783084Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783091Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783107Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783114Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783121Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783138Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783145Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783152Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
09348811101501INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
09348811101532INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
00757770636341Bausch + LombBausch & Lomb IncorporatedKAD2025-11-15
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