FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183524562
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR12-18412
Catalog number
BR12-18412
Device description
"DERLACKI Ossicle Holder,1.5mm x 4mm vertical groove,1.5mm x 2mm horizontal groove, 1mm teeth, 4 3/4"""
Published
2024-05-28
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
JYFClamp, Ossicle Holding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYFClamp, Ossicle HoldingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183524562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183524562008401835245628401835245620840183524562

GMDN Terms#

Term, Definition table
TermDefinition
Otologic clampA hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. 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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14026704805621PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
54026704805629PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
00887482043752Symmetry SheehyASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00887482114407Symmetry DerlackiASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00190660014919Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
00190660017767Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
M63334170280JEDMEDJEDMED INSTRUMENT COMPANYJYF2020-09-01
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