FDA.reportPublic FDA data

MemGuide

Primary DI
00812337020398
Brand
MemGuide
Company
DSM BIOMEDICAL, INC.
Model
30076-01
Catalog number
7351520
Device description
Porcine Dental Membrane
Published
2021-07-30
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
NPLBarrier, Animal Source, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812337020398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337020398008123370203988123370203980812337020398

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131107757
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M263W25000WizardBio Resorbable Calcium Phosphate Cement21004-05W250002019-01-02
00812337020442Drillable Bone Void Filler21005-0307.705.003S2023-01-11
00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
M26300110301005CopiOs® Bone Void Filler Sponge20101-0200-1103-010-052015-09-17
M26300110301010CopiOs® Bone Void Filler Sponge20101-0300-1103-010-102015-09-17
M26300110302001CopiOs® Bone Void Filler Paste20102-0100-1103-020-012015-09-17
M26300110302005CopiOs® Bone Void Filler Paste20102-0200-1103-020-052015-09-17
M26300110302010CopiOs® Bone Void Filler Paste20102-0300-1103-020-102015-09-17
M2630011301001CopiOs® Bone Void Filler Sponge20101-0100-1103-010-012015-09-17
M2630700582001CopiOs® Bone Void Filler Sponge20100-0107.00582.0012015-09-17
M2630700582003CopiOs® Bone Void Filler Sponge20100-0207.00582.0032015-09-17
M2630700582004CopiOs® Bone Void Filler Sponge20100-0307.00582.0042015-09-17
00812337020435BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc21003-04ABS-31012023-05-09
M263300700402DSM Biomedical Dental Bone Graft30070-042021-10-20
M263300700503DSM Biomedical Dental Bone Graft30070-052021-10-20
M263300700604DSM Biomedical Dental Bone Graft30070-062021-10-20
M263300700705DSM Biomedical Dental Bone Graft30070-072021-10-20
M263300700806DSM Biomedical Dental Bone Graft30070-082021-10-20
M263300700907DSM Biomedical Dental Bone Graft30070-092021-10-20

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