OsteoGen Block

Primary DI
00855286006358
Brand
OsteoGen Block
Company
Impladent, Ltd.
Model
OBB101517
Device description
OsteoGen Block. OsteoGen bone graft combined with a bovine achilles tendon carrier
Published
2023-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00855286006341PackageGS12In Commercial Distribution
00855286006358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855286006341008552860063418552860063410855286006341
00855286006358008552860063588552860063580855286006358

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.

Regulatory Flags#

DUNS number
199838400
Device count
1
Lot or batch
true
Expiration date on label
true

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
00855286006426OsteoGen Plugs - Extra LargeOPXL15202023-08-22
00855286006112OsteoGen StripOSL204032023-08-22
00855286006129OsteoGen StripOSL204032023-08-22
00855286006266OsteoGen Strip - SmallOSS122032023-08-22
00855286006341OsteoGen BlockOBB1015172023-08-22
00855286006433OsteoGen Plugs - Extra LargeOPXL15202023-08-22
00855286006013OsteoGen Plugs - Large, 10x20mmOPL10202015-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806387896760Renew-Cera, (BoneMedik-DM 0.3~0.5mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896777Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896784Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896791Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896807Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896814Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896821Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896838Renew-Cera, (BoneMedik-DM 0.5~1.0mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896845Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896852Renew-Cera, (BoneMedik-DM 0.3 ~ 0.5 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896869Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896876Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08800039000000THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000017THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000024THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000031THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000048THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000055THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000062THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000079THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000086THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000093THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000109THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000116THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000123THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000130THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000147THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000154THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000161THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000178THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15