FDA.reportPublic FDA data

VELOFIX™ PEEK CERVICAL CAGE

Primary DI
08800015954457
Brand
VELOFIX™ PEEK CERVICAL CAGE
Company
CG MedTech Co.,Ltd.
Model
PE002
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800015954457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800015954457088000159544578800015954457

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06
08800037574732Velofix™ SA Cervical CageTS09132026-05-06
08800308485804ANAX™ OCT Spinal SystemOS00902026-04-21
08800247357477SECULOK™ ACP SYSTEMFCA10192026-03-31
08800247357484SECULOK™ ACP SYSTEMFCA10212026-03-31
08800247357491SECULOK™ ACP SYSTEMFCA10232026-03-31
08800247357507SECULOK™ ACP SYSTEMFCA10252026-03-31
08800247357514SECULOK™ ACP SYSTEMFCA10272026-03-31
08800247357521SECULOK™ ACP SYSTEMFCA10292026-03-31
08800247357538SECULOK™ ACP SYSTEMFCA10312026-03-31
08800247357545SECULOK™ ACP SYSTEMFCA10332026-03-31
08800247357552SECULOK™ ACP SYSTEMFCA10352026-03-31
08800247357569SECULOK™ ACP SYSTEMFCA10372026-03-31
08800247357576SECULOK™ ACP SYSTEMFCA10392026-03-31
08800247357583SECULOK™ ACP SYSTEMFCA10412026-03-31
08800247357590SECULOK™ ACP SYSTEMFCA10432026-03-31
08800247357606SECULOK™ ACP SYSTEMFCA10452026-03-31
08800247357613SECULOK™ ACP SYSTEMFCA20312026-03-31
08800247357620SECULOK™ ACP SYSTEMFCA20332026-03-31

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ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
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