Rti Surgical, Inc.

Address:1800 A North Greene Street,Greenville,NC,27834,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

FILLER, BONE VOID, CALCIUM COMPOUND (MQV) (6) BONE GRAFTING MATERIAL, HUMAN SOURCE (NUN) (4)

Premarket Exempt

No Yes

Clear

RegenaVate™ Formable DBM RT, 2cc - 00854095006771 Catalog Number : 005302Z

Device Description : Formable DBM RT, 2cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc - 00854095006788 Catalog Number : 001504Z

Device Description : Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc - 00854095006795 Catalog Number : 001505Z

Device Description : Formable DBM, 1cm x 2cm x 0.5cm, 1cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc - 00854095006801 Catalog Number : 001510Z

Device Description : Formable DBM, 1cm x 4cm x 0.5cm, 2cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

BioSet® - 00854095006818 Catalog Number : 015700

Device Description : RT Allograft Paste, Syringe, 0.5cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BioSet® - 00854095006825 Catalog Number : 015701

Device Description : RT Allograft Paste, Syringe, 1cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BioSet® - 00854095006832 Catalog Number : 015705

Device Description : RT Allograft Paste, Syringe, 5cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BioSet® - 00854095006849 Catalog Number : 015710

Device Description : RT Allograft Paste, Syringe, 10cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BioSet® - 00854095006894 Catalog Number : 016702

Device Description : IC, RT Allograft Paste, 2cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BioSet® - 00854095006900 Catalog Number : 016705

Device Description : IC, RT Allograft Paste, 5cc

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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