OsteoGen Plugs - Extra Large

Primary DI
00855286006433
Brand
OsteoGen Plugs - Extra Large
Company
Impladent, Ltd.
Model
OPXL1520
Device description
OsteoGen Plugs. OsteoGen bone graft combined with a bovine achilles tendon carrier
Published
2023-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090794000OSTEOTAPEImpladent , Ltd.2009-12-10NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855286006433PackageGS15In Commercial Distribution
00855286006426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855286006433008552860064338552860064330855286006433
00855286006426008552860064268552860064260855286006426

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
199838400
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
00855286006136TriStar Screws - 3mm (Pack of 5)TRI-032015-10-27
00855286006143TriStar Screws - 4mm (Pack of 5)TRI-042015-10-27
00855286006150TriStar Screws - 5mm (Pack of 5)TRI-052015-10-27
00855286006167TriStar Screws - 6mm (Pack of 5)TRI-062015-10-27
00855286006174TriStar Screws - 8mm (Pack of 5)TRI-082015-10-27
00855286006181TriStar Screws - 10mm (Pack of 5)TRI-102015-10-27
00855286006198TriStar Screws - 12mm (Pack of 5)TRI-122015-10-27
00855286006204TriStar Screws - 14mm (Pack of 5)TRI-142015-10-27
00855286006211TriStar Screws - 15mm (Pack of 5)TRI-152015-10-27
00855286006228TriStar Screws - 18mm (Pack of 5)TRI-182015-10-27
00855286006235TriStar Screws - 21mm (Pack of 5)TRI-212015-10-27
00855286006242TriStar Screws - 24mm (Pack of 5)TRI-242015-10-27
00855286006273OsteoGen Strip - SmallOSS122032023-08-22
00855286006358OsteoGen BlockOBB1015172023-08-22
00855286006426OsteoGen Plugs - Extra LargeOPXL15202023-08-22
00855286006112OsteoGen StripOSL204032023-08-22
00855286006129OsteoGen StripOSL204032023-08-22
00855286006266OsteoGen Strip - SmallOSS122032023-08-22
00855286006341OsteoGen BlockOBB1015172023-08-22
00855286006013OsteoGen Plugs - Large, 10x20mmOPL10202015-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00813954026794SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954027005PLENA Graft 0.5cc SyringeCOLLAGEN MATRIX, INC.NPM2025-08-01
00813954027012PLENA Graft 0.5COLLAGEN 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
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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
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00614950027958MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027965MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
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00614950027996MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028009MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
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