FDA.report

PuraTAPE+

Primary DI
00813954028897
Brand
PuraTAPE+
Company
COLLAGEN MATRIX, INC.
Model
PGTPE+
Catalog number
PGTPE+
Device description
Collagen Dental Dressing
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGNWound Dressing With Animal-Derived Material(S)
LYCBone Grafting Material, Synthetic

Product Code Classifications

CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10813954028894PackageGS110In Commercial Distribution
00813954028897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081395402889410813954028894
00813954028897008139540288978139540288970813954028897

GMDN Terms

TermDefinition
General oral wound dressing, animal-derivedA collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature00

Contacts

PhoneEmail
(877) 540-3258info@puragraft.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 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
00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028484XENOFY-PXFP-050050XFP-0500502026-03-12
00813954028491XENOFY-PXFP-050100XFP-0501002026-03-12
00813954028507XENOFY-PXFP-050200XFP-0502002026-03-12
00813954028514XENOFY-PXFP-050400XFP-0504002026-03-12
00813954028521XENOFY-PXFP-051100XFP-0511002026-03-12
00813954028538XENOFY-PXFP-051200XFP-0512002026-03-12
10813954028436Tissue Specialists Resorbable Collagen PlugT5094000T50940002026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeT5091000T50910002026-03-09
00813954028453Tissue Specialists Resorbable Collagen MembraneT5096000T50960002026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneT5093000T50930002026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneT5098000T50980002026-03-09
10813954028542bioSTRIPOUSTPSOUSTPS2026-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.LYC2026-05-26
00813954028880PuraPLUG+COLLAGEN MATRIX, INC.KGN2026-05-26
10885632434303HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-05-22
00812593023010Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
00812593023027Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
30888277720729MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
20888277720739MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10813954028436Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028542bioSTRIPCOLLAGEN MATRIX, INC.LYC2026-03-09
10813954028559bioPLUGCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028566bioKOTECOLLAGEN MATRIX, INC.LYC2026-03-09
10381780545569PriMatrix®INTEGRA LIFESCIENCESKGN2026-03-04
14550565002269Cytrans GranulesGc America Inc.LYC2026-03-03
14550565002276Cytrans GranulesGc America Inc.LYC2026-03-03
D047014615Cytrans GranulesGc America Inc.LYC2026-03-03
D047014616Cytrans GranulesGc America Inc.LYC2026-03-03
00861092002637Cealogic RibbonRECIBIO, INC.KGN2026-03-01
00854780005515Architect FxHARBOR MEDTECH, INC.KGN2026-02-25
00813909013589Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013596Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013602Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013619Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013657Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013664Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013671Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17