FDA.report

BI-PHASE SYSTEM

Primary DI
00841036005993
Brand
BI-PHASE SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
01-0032
Catalog number
01-0032
Published
2017-01-04
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036005993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036005993008410360059938410360059930841036005993

GMDN Terms

TermDefinition
Craniofacial alignment rodA surgical instrument typically used in pairs to facilitate correct cranial orientation of craniofacial implants (e.g., fixation plates being attached to jaw bones) and other devices (e.g., craniofacial distractors) during their application in craniofacial surgery. It is typically designed as a long, thin, rigid rod made of high-grade stainless steel or titanium alloy with connectors at either end for attachment to the devices being aligned; it may have a knurled mid section (to provide better grip) onto which other instruments can be locked to assist the orientation procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags

DUNS number
046189866
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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