ANAX™ 5.5 SPINAL SYSTEM

GUDID 08800037544759

U&I CORPORATION

Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting
Primary Device ID08800037544759
NIH Device Record Key6d7a8593-f7eb-4e55-8c93-de17ddfd3d38
Commercial Distribution StatusIn Commercial Distribution
Brand NameANAX™ 5.5 SPINAL SYSTEM
Version Model NumberSF0380
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
GS108800037544759 [Primary]
GS108800037544759 [Primary]
GS108800037544759 [Primary]
GS108800037544759 [Primary]
GS108800037544759 [Primary]
GS108800037544759 [Primary]
GS108800037544759 [Primary]
GS108800037544759 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


[08800037544759]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

On-Brand Devices [ANAX™ 5.5 SPINAL SYSTEM]

08800037502247SFM0130
08800037502230SFM0120
08800015994644SFM0130
08800015994637SFM0120
08800037502254SFM0140
08800037502261OSS0300
08800037503589SF5400TSM
08800037503572SF5400CSM
08800037503565SF5380TSM
08800037503558SF5380CSM
08800037503541SF5360TSM
08800037503534SF5360CSM
08800037503527SF5340TSM
08800037503510SF5340CSM
08800037503503SF5320TSM
08800037503497SF5320CSM
08800037503480SF5300TSM
08800037503473SF5300CSM
08800037503466SF5280TSM
08800037503459SF5280CSM
08800037503442SF5260TSM
08800037503435SF5260CSM
08800037503428SF5240TSM
08800037503411SF5240CSM
08800037503404SF5220CSM
08800037503398SF5220TSM
08800015908191SFTA1460
08800015908184SFTA1450
08800015908177SFTA1440
08800015908160SFTA1430
08800015908153SFTA1420
08800015908146SFTA1410
08800015908139SFRA8095
08800015908122SFRA8090
08800015908115SFRA8085
08800015908108SFRA8080
08800015908092SFRA8075
08800015908085SFRA8070
08800015908078SFRA8065
08800015908061SFRA8060
08800015908054SFRA8055
08800015908047SFRA8050
08800015908030SFRA8045
08800015908023SFRA8040
08800015908016SFRA8035
08800015908009SFRA8030
08800015907996SFRA7595
08800015907989SFRA7590
08800015907972SFRA7585
08800015907965SFRA7580

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