FDA.report

OSS(TM) STEM FLARE REAMER

Primary DI
00880304111172
Brand
OSS(TM) STEM FLARE REAMER
Company
Biomet Orthopedics, LLC
Model
CP460476
Catalog number
CP460476
Published
2020-05-23
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
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304111172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304111172008803041111728803041111720880304111172

GMDN Terms

TermDefinition
Knee femur prosthesis trial, reusableA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
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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00889024706774Biomet®32-34169232-3416922026-03-12
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00889024706798Biomet®32-14815132-1481512026-03-12
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