SYNTHASOME, INC.

Address:13673 BOQUITA DR,DEL MAR,CA,92014,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

Mesh, Surgical, Polymeric (FTL) (6)

Premarket Exempt

Clear

X-Repair - B055009 Catalog Number : Z009

Device Description : X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 43mm (WxL)

Device Class : 2

Duns Number: 140697280

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

X-Repair - B05500930 Catalog Number : Z009-30

Device Description : X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 30mm (WxL)

Device Class : 2

Duns Number: 140697280

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

X-RepairSL - B055020160SL Catalog Number : Z020-160SL

Device Description : X‐RepairSL, Bioabsorbable surgical mesh, single‐layer 4mm x 160mm (WxL)

Device Class : 2

Duns Number: 140697280

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

X-RepairSL - B055021160SL Catalog Number : Z021-160SL

Device Description : X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 160mm (WxL)

Device Class : 2

Duns Number: 140697280

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

X-RepairSL - B05502280SL Catalog Number :

Device Description : X-RepairSL, Bioabsorbable surgical mesh, single layer, 12mm x 80mm (WxL)

Device Class : 2

Duns Number: 140697280

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

X-RepairSL - B05502480SL Catalog Number : Z024-80SL

Device Description : X-RepairSL, bioabsorbable surgical mesh, single-layer, 25mm x 80mm (WxL)

Device Class : 2

Duns Number: 140697280

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

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