FDA.report

Perfix™ MIS

Primary DI
08800015947756
Brand
Perfix™ MIS
Company
Innosys Co., Ltd.
Model
SS0240
Published
2017-10-27
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

Product Codes

CodeName
FZXGuide, surgical, instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800015947756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800015947756088000159477568800015947756

GMDN Terms

TermDefinition
Orthopaedic implant/instrument dismantling deviceA device designed to dismantle (take apart) the component parts of an implant or a surgical instrument that have previously been assembled. It may be used as a stand-alone device or in combination with another device to control the dismantling process of, e.g., complex implants (e.g., a modular vertebral implant that has to be dismantled if the combination of the component parts do not fit the required size) or instruments so that these are correctly disassembled, without causing damage to any of the parts. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

Other Devices From This Company

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08800037597892UniSpace® Stand-Alone C CageAUS10092024-12-07
08800037597908UniSpace® Stand-Alone C CageAUS10102024-12-07
08800037597915UniSpace® Stand-Alone C CageAUS10112024-12-07
08800037597922UniSpace® Stand-Alone C CageAUS10122024-12-07
08800037597939UniSpace® Stand-Alone C CageAUS10132024-12-07
08800037597946UniSpace® Stand-Alone C CageAUS10142024-12-07
08800247357088GENERAL HANDLEGH11202024-12-07
08800247357095GENERAL HANDLEGH11302024-12-07
08800247356920INNOVERSE SPINAL SYSTEMNP09112024-12-02
08800247356937INNOVERSE SPINAL SYSTEMNP09122024-12-02
08800247356944INNOVERSE SPINAL SYSTEMNP09132024-12-02
08800247356951INNOVERSE SPINAL SYSTEMNP09142024-12-02
08800247356968INNOVERSE SPINAL SYSTEMNP09152024-12-02
08800247356975INNOVERSE SPINAL SYSTEMNP09162024-12-02
08800247356982INNOVERSE SPINAL SYSTEMNP09172024-12-02
08800247356999INNOVERSE SPINAL SYSTEMNP09212024-12-02
08800247357002INNOVERSE SPINAL SYSTEMNP09222024-12-02
08800247357019INNOVERSE SPINAL SYSTEMNP09232024-12-02
08800247357026INNOVERSE SPINAL SYSTEMNP09242024-12-02
08800247357033INNOVERSE SPINAL SYSTEMNP09312024-12-02

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03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
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00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
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10705034578873N/AMedos International SàrlFZX2026-03-05
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09421038411926Dist Fem Cut Block Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411933Dist Fem Cut Block Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27