ANAX 5.5 Spinal System

GUDID 08800037550910

U&I CORPORATION

Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable
Primary Device ID08800037550910
NIH Device Record Key05f2d3b5-b82b-4a3b-9ca0-b996d3aed203
Commercial Distribution StatusIn Commercial Distribution
Brand NameANAX 5.5 Spinal System
Version Model NumberSFDS1004
Company DUNS688811082
Company NameU&I CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800037550910 [Primary]

FDA Product Code

HXWBENDER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


[08800037550910]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-23
Device Publish Date2021-08-13

On-Brand Devices [ANAX 5.5 Spinal System]

08800037550880SFS1043
08800037550927SFDS1005
08800037550910SFDS1004
08800037550903SFDS1003
08800037550934SFS1077

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