FDA.report

GRAFT PREP TABLE

Primary DI
00880304405288
Brand
GRAFT PREP TABLE
Company
Biomet Orthopedics, LLC
Model
904100
Catalog number
904100
Published
2017-07-28
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
HXDCLAMP

Product Code Classifications

CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304405288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304405288008803044052888803044052880880304405288

GMDN Terms

TermDefinition
Graft preparation stationA non-sterile assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and the necessary tools (e.g., an Allen key) to hold and tension the graft. It may be used for a variety of graft such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. This is a reusable device intended to be sterilized prior to use.

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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00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

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