FDA.report

Perfix™ Spinal System

Primary DI
08800015953030
Brand
Perfix™ Spinal System
Company
U&I CORPORATION
Model
SN0015
Published
2017-11-01
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800015953030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800015953030088000159530308800015953030

GMDN Terms

TermDefinition
Bone distraction forcepsA hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. 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

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08800037567284Dyna Locking Trochanteric NailNG23752023-05-23
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08800037567307Dyna Locking Trochanteric NailNG23852023-05-23
08800037567314Dyna Locking Trochanteric NailNG23902023-05-23
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08800037567345Dyna Locking Trochanteric NailNG24052023-05-23
08800037567352Dyna Locking Trochanteric NailNG24102023-05-23
08800037567369Dyna Locking Trochanteric NailNG24152023-05-23
08800037567376Dyna Locking Trochanteric NailNG24202023-05-23
08800037575845Dyna Locking Trochanteric NailNG09102023-05-23
08800037575852Dyna Locking Trochanteric NailNG09112023-05-23
08800037575869Dyna Locking Trochanteric NailNG09122023-05-23
08800037575876Dyna Locking Trochanteric NailNG09132023-05-23
08800037575883Dyna Locking Trochanteric NailNG09142023-05-23
08800037575890Dyna Locking Trochanteric NailNG09202023-05-23
08800037575906Dyna Locking Trochanteric NailNG09212023-05-23
08800037575913Dyna Locking Trochanteric NailNG09222023-05-23

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