FDA.report

InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-Mesh

Primary DI
08809471726394
Brand
InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-Mesh
Company
Cowellmedi Co.,Ltd
Model
TS17251
Published
2024-05-24
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

Product Codes

CodeName
NPKBarrier, Synthetic, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
NPKBarrier, Synthetic, IntraoralDental2

Premarket Submissions

SubmissionSupplement
K211554000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K211554000InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.2023-02-24NPK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809471726394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809471726394088094717263948809471726394

GMDN Terms

TermDefinition
Pliable-polymer dental regeneration membrane, non-bioabsorbableA sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
688753763
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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08800039006682TBS PTFE membranePURGO BIOLOGICS Inc.NPK2025-07-24
D767C0609010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0613010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
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D767C0635010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0639010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0641010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
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08800016107166InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
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08800016107258InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
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06438408005572Inion GTR™Inion OyNPK2023-12-19
06438408007279Inion GTR™Inion OyNPK2023-12-19
06438408010750Inion GTR™Inion OyNPK2023-12-19
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08800039000604OpenTexPURGO BIOLOGICS Inc.NPK2023-05-17