FDA.report

ANAX™ 5.5 SPINAL SYSTEM

Primary DI
08800037525789
Brand
ANAX™ 5.5 SPINAL SYSTEM
Company
U&I CORPORATION
Model
SFS1074
Published
2020-02-27
Public version status
New
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
HWXTAP, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800037525789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800037525789088000375257898800037525789

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

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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08800037567307Dyna Locking Trochanteric NailNG23852023-05-23
08800037567314Dyna Locking Trochanteric NailNG23902023-05-23
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08800037567345Dyna Locking Trochanteric NailNG24052023-05-23
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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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