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

Bone Grafting Material, Animal Source (NPM) (6) Barrier, Animal Source, Intraoral (NPL) (3) Dressing, Wound, Collagen (KGN) (1)

Premarket Exempt

Clear

GEM™ Bone Graft - 00850001118101 Catalog Number :

Device Description : Osteoconductive Bone Matrix, 2.0cc (Particle Size 0.25-1.0mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

GEM™ Bone Graft - 00850001118118 Catalog Number :

Device Description : Osteoconductive Bone Matrix, 4.0cc (Particle Size 0.25-1.0mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

GEM™ Bone Graft - 00850001118125 Catalog Number :

Device Description : Osteoconductive Bone Matrix, 1.0cc (Particle Size 1.0-2.0mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

GEM™ Bone Graft - 00850001118132 Catalog Number :

Device Description : Osteoconductive Bone Matrix, 2.0cc (Particle Size 1.0-2.0mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

GEM™ Bone Graft - 00850001118149 Catalog Number :

Device Description : Osteoconductive Bone Matrix in Syringe, 0.25cc (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 - 00850001118156 Catalog Number :

Device Description : Osteoconductive Bone Matrix in Syringe, 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™ Synthetic Bone Graft - 00850001118163 Catalog Number :

Device Description : Synthetic Mineral-Collagen Composite Bone Graft, 0.5cc (9mm x 8mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM™ Synthetic Bone Graft - 00850001118170 Catalog Number :

Device Description : Synthetic Mineral-Collagen Composite Bone Graft, 1.0cc (11mm x 10mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM™ Synthetic Bone Graft - 00850001118187 Catalog Number :

Device Description : Synthetic Mineral-Collagen Composite Bone Graft, 2.0cc (11mm x 21mm)

Device Class : 2

Duns Number: 079604282

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

GEM™ Wound Dressing Tape - 10850001118191 Catalog Number :

Device Description : Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm

Device Class :

Duns Number: 079604282

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 10

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