FDA.reportPublic FDA data

PuraFILL

Primary DI
00813954026749
Brand
PuraFILL
Company
COLLAGEN MATRIX, INC.
Model
PFPLG1020
Catalog number
PFPLG1020
Device description
Bone Graft Composite Plug
Published
2025-03-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813954026746PackageGS110In Commercial Distribution
00813954026749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081395402674610813954026746
00813954026749008139540267498139540267490813954026749

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material 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 typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to 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.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(877) 540-3258info@puragraft.com

Regulatory Flags#

DUNS number
176262442
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954028767Gibson Healthcare Alloplast6247-9926247-9922026-05-26
00813954028774Gibson Healthcare Alloplast6248-0086248-0082026-05-26
00813954028781Gibson Healthcare Alloplast6248-0176248-0172026-05-26
00813954028873PuraKOTE+PGKTE+PGKTE+2026-05-26
00813954028880PuraPLUG+PGPLG+PGPLG+2026-05-26
00813954028897PuraTAPE+PGTPE+PGTPE+2026-05-26
00813954028385collatene509101050910102026-05-05
00813954028620AmpliDermAMPLIDERM-ROUND-10AMPLIDERM-ROUND-102026-04-06
00813954028637AmpliDermAMPLIDERM-THICK-15X20AMPLIDERM-THICK-15X202026-04-06
00813954028644AmpliDermAMPLIDERM-THICK-20X30AMPLIDERM-THICK-20X302026-04-06
00813954028651AmpliDermAMPLIDERM-THICK-30X40AMPLIDERM-THICK-30X402026-04-06
00813954028668AmpliDermAMPLIDERM-THIN-15X20AMPLIDERM-THIN-15X202026-04-06
00813954028675AmpliDermAMPLIDERM-THIN-20X30AMPLIDERM-THIN-20X302026-04-06
00813954028682AmpliDermAMPLIDERM-THIN-30X40AMPLIDERM-THIN-30X402026-04-06
00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028736SALVIN OraCOTE+ORACOTE-PLUS-PKG-10ORACOTE-PLUS-PKG-102026-03-18
00813954028743SALVIN OraPLUG+ORAPLUG-PLUS-PKG-10ORAPLUG-PLUS-PKG-102026-03-18
00813954028750SALVIN OraTAPE+ORATAPE-PLUS-PKG-10ORATAPE-PLUS-PKG-102026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
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
08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
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