UniSpace® Stand-Alone C Cage

Primary DI
08800247355947
Brand
UniSpace® Stand-Alone C Cage
Company
CG MedTech Co.,Ltd.
Model
AU0140
Published
2024-06-22
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
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800247355947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800247355947088002473559478800247355947

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27
08800247359945UniSpace® TPLIF CageTU02202026-06-27
08800247359952UniSpace® TPLIF CageTU02302026-06-27
08800247359969UniSpace® TPLIF CageTU02402026-06-27
08800247359976UniSpace® TPLIF CageTU02502026-06-27
08800247359983UniSpace® TPLIF CageTU02602026-06-27
08800247359990UniSpace® TPLIF CageTU02702026-06-27
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310650ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310660ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310670ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310680ORTHOMEDORTHO-MED, INC.HTW2026-07-22
00190776403270MillenniumAvalign Technologies, Inc.HTW2026-07-21
08059386748688Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2026-07-21
B504OM19S17050BrasselerProvisionHTW2026-07-20
B504OM3162880SynthesProvisionHTW2026-07-20
B504OM4058830BiometProvisionHTW2026-07-20
B504OM4058890BiometProvisionHTW2026-07-20
B504OM542022S0StrykerProvisionHTW2026-07-20
B504OM7024470StrykerProvisionHTW2026-07-20
B504OMA37330MedartisProvisionHTW2026-07-20
B504OMAR1214L0ArthrexProvisionHTW2026-07-20
B504OMAR1217L0ArthrexProvisionHTW2026-07-20
B504OMCSS07247SQ0WrightProvisionHTW2026-07-20
B504OMKM166310260BrasselerProvisionHTW2026-07-20
B504OMKM166310680BrasselerProvisionHTW2026-07-20
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17