FDA.report

VENADO Carbonate Apatite Strip

Primary DI
00813954021980
Brand
VENADO Carbonate Apatite Strip
Company
COLLAGEN MATRIX, INC.
Model
4817-T122101
Device description
Carbonate Apatite Strip 10cc (12.5 x 2 x 0.4cm, 1 Strip)
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813954021980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954021980008139540219808139540219800813954021980

GMDN Terms

TermDefinition
Composite bone graftAn implantable device that combines various bone substitute materials and/or bone growth factors to serve as a structural bone replacement typically when bone is lost due to trauma or osteoporosis. It is available in a variety of combinations such as collagen/ceramic, or polytetrafluoroethylene (PTFE) with carbon fibres.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
176262442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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