AccessGUDID - DEVICE: GEM 21S® (00850001118002)

GUDID

Device Identifier (DI) Information

Brand Name: GEM 21S®
Version or Model: LBGEM05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LYNCH BIOLOGICS, LLC

Primary DI Number: 00850001118002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079604282 *Terms of Use

Device Description: Growth-Factor Enhanced Matrix for Periodontal Regeneration

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:	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
NPZ	Bone Grafting Material, Dental, With Biologic Component
NQA	Biologic Material, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040013	000
P040013	014
P040013	015
P040013	016
P040013	018
P040013	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
Special Storage Condition, Specify: Protect from light
Special Storage Condition, Specify: Do not freeze
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.5 Gram

Device Record Status

Public Device Record Key: 457b7521-fbca-448d-b068-74c0a7031f94
Public Version Date: November 19, 2018
Public Version Number: 1
DI Record Publish Date: October 18, 2018