PLENA Graft 0.5

Primary DI
00813954027012
Brand
PLENA Graft 0.5
Company
COLLAGEN MATRIX, INC.
Model
PMC0510
Catalog number
PMC0510
Device description
Anorganic Bone Mineral
Published
2025-07-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813954027012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954027012008139540270128139540270120813954027012

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, animal-derivedA bioabsorbable, implantable device made primarily of animal-derived materials (e.g., bovine, porcine) intended to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities and defects. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
844-862-7846info@sweden-martina.com

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954028798Dyna-Bone Plug10.905.062510.905.06252026-07-02
00813954028804Dyna-Bone Plug10.905.102010.905.10202026-07-02
M440SGG0500StarGraft GranulesSGG0502015-10-23
M440SGG1000StarGraft GranulesSGG1002015-10-23
M440SGG2000StarGraft GranulesSGG2002015-10-23
M440SGG3500StarGraft GranulesSGG3502015-10-23
M440SGP0500StarGraft PuttySGP0502015-10-23
M440SGP1000StarGraft PuttySGP1002015-10-23
M440SGP2000StarGraft PuttySGP2002015-10-23
10813954020874OssiMend BLOCKMCCB20042015-10-22
10813954021024PlatFORM CM StripCM464202015-10-22
10813954024223Gibson Healthcare® Bone Graft Plug5824-4042021-07-26
10813954024230Gibson Healthcare® Bone Graft Plug5824-4132021-07-26
10813954024261OsteoMaxx PlugXA6252021-07-26
10813954024278OsteoMaxx PlugXA1202021-07-26
10813954024285OsteoPlug™OGP06252021-10-26
10813954024292OsteoPlug™OGP10202021-10-26
10813954024407PreservaRidge™ PlugPRPREG2022-01-17
10813954024544PreservaRidge™ PlugPRPSLM2022-01-17
10813954024551Opus Strip713212202022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954027005PLENA Graft 0.5cc SyringeCOLLAGEN MATRIX, INC.NPM2025-08-01
00813954027029PLENA Graft 1.0COLLAGEN MATRIX, INC.NPM2025-07-15
00813954026732PuraFILLCOLLAGEN MATRIX, INC.NPM2025-03-26
00813954026749PuraFILLCOLLAGEN MATRIX, INC.NPM2025-03-26
00813954026183REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026190REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026138EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
00813954026145EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
00614950028443OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028450OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028467OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028474OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028481OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028498OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028504OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028511OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00813954025315RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00813954025322RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00614950027934MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027941MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027958MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027965MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027972MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027989MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027996MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028009MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028016MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028023MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27