DEVICE: Geistlich Mucograft® Seal (07610221011308)
Device Identifier (DI) Information
Geistlich Mucograft® Seal
50-0808
In Commercial Distribution
Geistlich Pharma AG
50-0808
In Commercial Distribution
Geistlich Pharma AG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Dental soft-tissue matrix implant, animal-derived | A sterile bioabsorbable material intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, primarily through promotion of new blood vessels; it is indicated for various oral soft tissue augmentation procedures (e.g. alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). 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 to soft tissue by properly prepared flaps during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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NPL | Barrier, Animal Source, Intraoral |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K140518 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 8 Millimeter |
Device Record Status
8a17129a-148b-4398-a71a-acf6eabc4d53
August 09, 2018
3
September 01, 2015
August 09, 2018
3
September 01, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined