LYNCH BIOLOGICS, LLC

LYNCH BIOLOGICS, LLC

Address:393 Nichol Mill,Franklin,TN,37067,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Barrier, Animal Source, Intraoral (NPL) (7) Bone Grafting Material, Animal Source (NPM) (2) Biologic Material, Dental (NQA) (1) Bone Grafting Material, Dental, With Biologic Component (NPZ) (1)

Premarket Exempt

No

Clear

GEM 21S® - 00850001118002 Catalog Number :

Device Description : Growth-Factor Enhanced Matrix for Periodontal Regeneration

Device Class : 3

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPZ, NQA

Prescription Use : Yes

Device Count : 1

GEM Adapt™ - 00850001118019 Catalog Number :

Device Description : Resorbable Collagen Membrane, 15mm x 20mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM Adapt™ - 00850001118026 Catalog Number :

Device Description : Resorbable Collagen Membrane, 20mm x 30mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM Adapt™ - 00850001118033 Catalog Number :

Device Description : Resorbable Collagen Membrane, 30mm x 40mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM Extend™ - 00850001118040 Catalog Number :

Device Description : Resorbable Collagen Membrane, 15mm x 20mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM Extend™ - 00850001118057 Catalog Number :

Device Description : Resorbable Collagen Membrane, 20mm x 30mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM Extend™ - 00850001118064 Catalog Number :

Device Description : Resorbable Collagen Membrane, 30mm x 40mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM Cap™ - 00850001118071 Catalog Number :

Device Description : Resorbable Collagen Membrane, 12mm x 16mm

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM™ Bone Graft - 00850001118088 Catalog Number :

Device Description : Osteoconductive Bone Matrix, 0.5cc (Particle Size 0.25-1.0mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

GEM™ Bone Graft - 00850001118095 Catalog Number :

Device Description : Osteoconductive Bone Matrix, 1.0cc (Particle Size 0.25-1.0mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

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