FDA.report

BI-POLAR™ REMOVAL INSTRUMENT

Primary DI
05019279461561
Brand
BI-POLAR™ REMOVAL INSTRUMENT
Company
Biomet Uk Ltd
Model
31-479271
Catalog number
31-479271
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
HTDFORCEPS

Product Code Classifications

CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05019279461561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05019279461561050192794615615019279461561

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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
219322575
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
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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05019279439942Oxford® Partial Knee System32-42297532-4229752020-05-23
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00887868354724Oxford® Partial Knee System1665731665732025-01-10
00887868354731Oxford® Partial Knee System1665741665742025-01-10
00887868354748Oxford® Partial Knee System1665751665752025-01-10
00887868354755Oxford® Partial Knee System1665761665762025-01-10
00887868354762Oxford® Partial Knee System1665771665772025-01-10
00887868354779Oxford® Partial Knee System1665781665782025-01-10
00887868354786Oxford® Partial Knee System1665791665792025-01-10
00887868354793Oxford® Partial Knee System1665801665802025-01-10
00887868354809Oxford® Partial Knee System1665811665812025-01-10
00887868354816Oxford® Partial Knee System1668451668452025-01-10

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