FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183521196
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR30-39724
Catalog number
BR30-39724
Device description
"WOLFF Plaster Cast Breaker, 9 1/2"""
Published
2024-02-06
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
LGGInstrument, Cast Application/Removal, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183521196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183521196008401835211968401835211960840183521196

GMDN Terms#

Term, Definition table
TermDefinition
Cast breakerA manual surgical instrument with strong, curved blades used to grasp and break apart hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with curved serrated (serrated on the inside to provide grip) blades. These blades are prised between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create a grip on the plaster that can then be broken off in pieces. It is typically 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421526MillenniumAvalign Technologies, Inc.LGG2026-05-05
00810058670533Professional Surgical Instruments Co., Inc. Professional Surgical Instruments Co., Inc.LGG2026-02-12
00194613087906MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-08-01
04049047005001GimmiGimmi GmbHLGG2025-04-02
00194613008345MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-03-21
00840306823039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LGG2025-01-17
00887482044421Symmetry Wolff-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482054772Symmetry Wolfe-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482037287Symmetry WaltonASPEN SURGICAL PRODUCTS, INC.LGG2024-08-12
00840183517687BR Surgical, LLCBR Surgical, LLCLGG2024-03-14
00840183505738BR Surgical, LLCBR Surgical, LLCLGG2024-03-13
00888515326071BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
00888515326088BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
14026704722300KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
44026704722301KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
G586N5166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166370Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166480Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95171160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95174160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95177160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95182410Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95192310Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
00842331194016Novo Surgical Inc. NOVO SURGICAL, INC.LGG2023-12-07
14026704722294KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
44026704722295KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
00190776283667AvalignAvalign Technologies, Inc.LGG2023-09-28
00840183502652BR Surgical, LLCBR Surgical, LLCLGG2023-05-26
00842962122174HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29