FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183527464
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR44-38501
Catalog number
BR44-38501
Device description
DIETER-HOUSE Malleus nipper, micro, upward, 1.3mm, 3 1/4”
Published
2024-07-19
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
JYRNipper, Malleus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYRNipper, MalleusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183527464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183527464008401835274648401835274640840183527464

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear malleus nipperA hand-held manual surgical instrument intended to be used to cut the malleus (hammer-shaped lateral bone of the group of three that form the sound-transmitting ossicles in the middle ear). It is typically a ring-handled instrument with, distal to a pivot pin, a set of blades: one slides back and forth to operate a set of jaws for cutting, and the other is stationary and may end in a sharpened anvil or a hook. In the anvil design, the sliding blade opens and closes a second sharpened blade against the anvil. In the hook design, the sliding blade closes against the hook. 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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00840306822704Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00810158211636PRINCETONPrinceton Medical Group, Inc.JYR2024-03-26
00810158210738PRINCETONPrinceton Medical Group, Inc.JYR2024-03-08
00842962144633HNM MedicalHNM STAINLESS, LLC.JYR2024-03-08
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00810158210271PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
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