FDA.reportPublic FDA data

Cytoplast™ Osteo-Mesh TM-300

Primary DI
D765TM2534NS0
Brand
Cytoplast™ Osteo-Mesh TM-300
Company
Osteogenics Biomedical Inc
Model
TM2534NS
Device description
Titanium Ridge Augmentation Mesh, 25 mm x 34 mm, Non-sterile
Published
2016-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D765TM2534NS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length34Millimeter
Width25Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123853058
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D765ZL1000ZCOREZL1002016-04-29
D765ZL2000ZCOREZL2002016-04-29
D765ZS0500ZCOREZS0502016-04-29
D765ZS1000ZCOREZS1002016-04-29
D765ZS2000ZCOREZS2002016-04-29
D765ZS4000ZCOREZS4002016-04-29
D765ZXSOCKET100ZCORE™ EXPANDZXSOCKET-102025-04-14
D765ZXSOCKET50ZCORE™ EXPANDZXSOCKET-52025-04-14
D765ZY0250ZCOREZY0252016-04-29
D765ZY025M20ZCOREZY0252018-12-07
D765ZY0500ZCOREZY0502016-04-29
D765ZY050M20ZCOREZY0502018-12-07
D765ZY1000ZCOREZY1002016-04-29
D765ZXSOCKET10ZCORE™ EXPANDZXSOCKET-12025-04-14
D765ZXSINUSL0ZCORE™ EXPANDZXSINUSL2021-06-25
D765ZXSINUSS0ZCORE™ EXPANDZXSINUSS2021-06-25
D765ZXSOCKET0ZCORE™ EXPANDZXSOCKET2021-06-25
D765ZF0500ZCORE FORMZF0502021-03-12
D765ZF1000ZCORE FORMZF1002021-03-12
D765ZF2000ZCORE FORMZF2002021-03-12

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