FDA.report

Innomed, Inc.

Primary DI
00840277124241
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
5275-02
Catalog number
5275-02
Device description
Garnetti Flat Punch for Hip Cup & Knee Revision
Published
2022-08-08
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

Product Codes

CodeName
HWPPunch, Femoral Neck

Product Code Classifications

CodeDeviceSpecialtyClass
HWPPunch, Femoral NeckOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277124241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277124241008402771242418402771242410840277124241

GMDN Terms

TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
878427491
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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