FDA.reportPublic FDA data

MEDPOR CONTAIN

Primary DI
07613252084464
Brand
MEDPOR CONTAIN
Company
Stryker Leibinger GmbH & Co. KG
Model
81065
Catalog number
81065
Device description
MEDPOR¿ CONTAIN? Implant Sheet
Published
2015-09-24
Public version status
Update
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
NPKBarrier, synthetic, intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPKBarrier, Synthetic, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091120000MEDPOR CONTAIN IMPLANTPorex Surgical, Inc.2010-03-19NPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252084464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252084464076132520844647613252084464

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length45Millimeter
Width35Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08
04546540143273NA01-1973001-197302016-12-08
04546540166623NA09-0146109-014612017-01-11
04546540166630NA09-0146209-014622017-01-11
04546540215161NA37-1027237-102722016-12-08
04546540215222NA37-1041137-104112016-12-08
04546540215291NA37-1093037-109302016-12-08
04546540215413NA37-1246137-124612016-12-08
04546540217059NA41-3679241-367922016-12-08
04546540217066NA41-3679341-367932016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336100206Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPK2025-11-11
00841336100213Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPK2025-11-11
08800016105865InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2025-10-14
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
D767C0617010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
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
08800016107135InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107142InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107159InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107166InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107173InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107180InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107241InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107258InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016108002InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144963InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144987InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144994InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726370InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726387InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726394InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726400InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
D767C0501010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0503010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0505010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0507010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10