FDA.report

U2 Total Knee System

Primary DI
04719886907186
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
9423-6220
Catalog number
9423-6220
Device description
PSA Tibial punch, #3~#4
Published
2025-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04719886907186PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+886229294567tw.service@unitedorthopedic.com

Regulatory Flags

DUNS number
656700556
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
true
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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