FDA.reportPublic FDA data

Straumann® Jason® membrane

Primary DI
04260396255149
Brand
Straumann® Jason® membrane
Company
botiss biomaterials GmbH
Model
BS-681520
Device description
Native pericardium GBR / GTR membrane
Published
2018-11-27
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

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
04260396255149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260396255149042603962551494260396255149

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
Length15Millimeter
Width20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341685939
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260396252117cerabone®MEUS-1510MEUS-15102023-03-13
04260396252124cerabone®MEUS-1511MEUS-15112023-03-13
04260396252131cerabone®MEUS-1512MEUS-15122023-03-13
04260396252148cerabone®MEUS-1515MEUS-15152023-03-13
04260396252155cerabone®MEUS-1520MEUS-15202023-03-13
04260396252162 cerabone®MEUS-1521MEUS-15212023-03-13
04260396252179cerabone®MEUS-1522MEUS-15222023-03-13
04260396252186cerabone®MEUS-1525MEUS-15252023-03-13
04260396255170Jason® membraneMEUS-681520MEUS-6815202023-03-13
04260396255187Jason® membraneMEUS-682030MEUS-6820302023-03-13
04260396255194Jason® membraneMEUS-683040MEUS-6830402023-03-13
04260396251509Straumann® cerabone®BS-1510BS-15102019-02-15
04260396251516Straumann® cerabone®BS-1511BS-15112019-02-15
04260396251523Straumann® cerabone®BS-1512BS-15122019-02-15
04260396251530Straumann® cerabone®BS-1515BS-15152019-02-15
04260396251547Straumann® cerabone®BS-1520BS-15202019-02-15
04260396251561Straumann® cerabone®BS-1521BS-15212019-02-15
04260396251585Straumann® cerabone®BS-1522BS-15222019-02-15
04260396251592Straumann® cerabone®BS-1525BS-15252019-02-15
04260396255156Straumann® Jason® membraneBS-6820302018-11-27

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Primary DI, Brand, Company table
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