AccessGUDID - DEVICE: Straumann Emdogain (07630031747372)

GUDID

Device Identifier (DI) Information

Brand Name: Straumann Emdogain
Version or Model: Emdogain
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 075.132
Company Name: Institut Straumann AG

Primary DI Number: 07630031747372
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: Straumann Emdogain MI 0.15ml

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:	No
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	024

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: 0.6 Milliliter
Total Volume: 0.15 Milliliter

Device Record Status

Public Device Record Key: e4e9b051-3ee9-4ee7-8281-b66cc53cbd5b
Public Version Date: August 14, 2020
Public Version Number: 1
DI Record Publish Date: August 06, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(801)448-8168
Email: info.usa@straumann.com

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