FDA.reportPublic FDA data

THE Graft Collagen

Primary DI
08800039005029
Brand
THE Graft Collagen
Company
PURGO BIOLOGICS Inc.
Model
TCB-04
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K230305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230305000THE Graft CollagenPurgo Biologics, Inc.2024-07-24NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039005029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039005029088000390050298800039005029

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687429456
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039007979CYTOSHIELDCYSD-24302026-07-22
08800039007986CYTOSHIELDCYSD-2430-52026-07-22
08800039007993CYTOSHIELDCYSD-17252026-07-22
08800039008006CYTOSHIELDCYSD-1725-52026-07-22
08800039008013TBS PTFE SutureS-PTFE3022D2026-07-22
08800039008020TBS PTFE SutureS-PTFE4022D2026-07-22
08800039008037TBS PTFE SutureS-PTFE5022D2026-07-22
08800039000123THE GraftTG-AS252018-10-15
08800039000130THE GraftTG-AS052018-10-15
08800039000147THE GraftTG-AS102018-10-15
08800039000277THE GraftTG-BS252018-10-15
08800039000284THE GraftTG-BS052018-10-15
08800039000291THE GraftTG-BS102018-10-15
08800039006651TBS PTFE SuturePTFE3022 2025-07-24
08800039006668TBS PTFE SuturePTFE4022 2025-07-24
08800039006675TBS PTFE SuturePTFE5022 2025-07-24
08800039006682TBS PTFE membraneTBSRGN082025-07-24
08800039006354BiotexBT3019D2025-04-24
08800039006361BiotexBT4019D2025-04-24
08800039006378BiotexBT5019D2025-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809186541299EquimatrixNibec Co., Ltd.NPM2026-10-06
08809186540926EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540933EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540940EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540957EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540964EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540971EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540988EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540995EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541305EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541312EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541329EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541336EquimatrixNibec Co., Ltd.NPM2026-09-29
08800045217584Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217591Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217607Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217614Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217621Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217638Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217645Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
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