ANAX 5.5™ SPINAL SYSTEM

GUDID 08800247357330

CG MedTech Co.,Ltd.

Surgical screwdriver, reusable
Primary Device ID08800247357330
NIH Device Record Keye4f8f4ee-9a88-4975-b2f4-043a47fd8e5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameANAX 5.5™ SPINAL SYSTEM
Version Model NumberSF0110
Company DUNS688811082
Company NameCG MedTech Co.,Ltd.
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 Datetrue
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
GS108800247357330 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


[08800247357330]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-24
Device Publish Date2025-02-16

Devices Manufactured by CG MedTech Co.,Ltd.

08800247357217 - INNOVERSE Spinal System2025-02-24
08800247357224 - INNOVERSE Spinal System2025-02-24
08800247357231 - INNOVERSE Spinal System2025-02-24
08800247357248 - INNOVERSE Spinal System2025-02-24
08800247357255 - INNOVERSE Navigation Instruments2025-02-24
08800247357262 - INNOVERSE Navigation Instruments2025-02-24
08800247357279 - INNOVERSE Navigation Instruments2025-02-24
08800247357286 - INNOVERSE Navigation Instruments2025-02-24

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