AccessGUDID - DEVICE: Geistlich Mucograft® Seal (07610221011308)

GUDID

Device Identifier (DI) Information

Brand Name: Geistlich Mucograft® Seal
Version or Model: 50-0808
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Geistlich Pharma AG

Primary DI Number: 07610221011308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480781728 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
NPL	Barrier, Animal Source, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 8a17129a-148b-4398-a71a-acf6eabc4d53
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2015