AccessGUDID - DEVICE: Straumann Emdogain (07630031730015)

GUDID

Device Identifier (DI) Information

Brand Name: Straumann Emdogain
Version or Model: Emdogain
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 075.114W
Company Name: Institut Straumann AG

Primary DI Number: 07630031730015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.3 ml (30 mg/ml), Straumann PrefGel 3 x 0.6 ml (24% EDTA)

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:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45481	Periodontal root surface regeneration material	A bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. It is typically presented in the form of a gel, or as a solution and enamel matrix material that is mixed into a gel prior to application. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NQA	Biologic Material, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P930021	020

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

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.9 Milliliter
Total Volume: 1.8 Milliliter

Device Record Status

Public Device Record Key: c5be8dbe-9562-420f-985d-fdbc9a6c68f9
Public Version Date: March 14, 2019
Public Version Number: 1
DI Record Publish Date: March 06, 2019