Artelon

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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) (8) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (4)

Premarket Exempt

Clear

FlexBand Plus - 00850003396101 Catalog Number :

Device Description : FlexBand Plus 0.3 x 32 Strip with Suture

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

FlexBand - 00850003396118 Catalog Number :

Device Description : FlexBand 0.5 x 24 Strip

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

FlexBand - 00850003396125 Catalog Number :

Device Description : FlexBand 0.3 x 24 Strip

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

FlexBand - 00850003396132 Catalog Number :

Device Description : FlexBand 0.7 x 24 Strip

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

FlexBand Eyelet Anchor - 00850003396149 Catalog Number : 81001

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

ALT Suture Anchor - 00850003396156 Catalog Number : 61017

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

ATL Suture Anchor Multi Kit - 00850003396163 Catalog Number : 71016

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : MBI, FTL

Prescription Use : Yes

Device Count : 1

ATL Suture Anchor Solo Kit - 00850003396170 Catalog Number : 51004

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : MBI, FTL

Prescription Use : Yes

Device Count : 1

FlexBand - 00868047000304 Catalog Number :

Device Description : FlexBand 4 x 6 Mesh

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

FlexBand - 00868047000311 Catalog Number :

Device Description : FlexBand 3 x 4 Mesh

Device Class : 2

Duns Number: 066284070

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

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