FDA.report

U2™ Knee

Primary DI
04719872175018
Brand
U2™ Knee
Company
UNITED ORTHOPEDIC CORP.
Model
9303-5104-RA
Catalog number
9303-5104-RA
Device description
PS Housing punch
Published
2017-06-29
Public version status
Update
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

Contact Domains

Product Codes

CodeName
HWPPunch, Femoral Neck

Product Code Classifications

CodeDeviceSpecialtyClass
HWPPunch, Femoral NeckOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04719872175018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04719872175018047198721750184719872175018

GMDN Terms

TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+886229294567service@uoc.com.tw

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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