FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JYRNipper, Malleus

Product Code Classifications

CodeDeviceSpecialtyClass
JYRNipper, MalleusEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183527464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183527464008401835274648401835274640840183527464

GMDN Terms

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
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

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

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