GEM 21S

Primary DI
D749210005201803066072
Brand
GEM 21S
Company
LUITPOLD PHARMACEUTICALS, INC.
Model
N/A
Device description
Growth-factor Enhanced Matrix for Periodontal Regeneration
Published
2016-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D749210005201803066072PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal root surface regeneration materialA 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.

Contacts#

Phone, Email table
PhoneEmail
1-800-874-2334info@osteohealth.com

Regulatory Flags#

DUNS number
002033710
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D749210005201812047282GEM 21SN/A2018-01-11
D749210005201812047283GEM 21SN/A2018-06-27
D749210005201702204325GEM 21SN/A2015-04-10
D749210005201702284309GEM 21SN/A2015-04-10
D749210005201702284310GEM 21SN/A2015-04-10
D749210005201705025017GEM 21SN/A2015-04-10
D749210005201705025058GEM 21SN/A2015-04-10
D749210005201705025059GEM 21SN/A2015-04-10
D749210005201705055102GEM 21SN/A2015-05-11
D749210005201705055214GEM 21SN/A2015-08-07
D749210005201705065222GEM 21SN/A2015-08-07
D749210005201705065285GEM 21SN/A2015-10-05
D749210005201705075379GEM 21SN/A2015-11-30
D749210005201803066071GEM 21SN/A2016-03-31
D749210005201803066183GEM 21SN/A2016-06-30
D749210005201803066213GEM 21SN/A2016-09-27
D749210005201803066394GEM 21SN/A2017-02-06