XIROS LTD

Address:SPRINGFIELD HOUSE,YEADON Leeds,GB

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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

Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (3) Mesh, Surgical, Polymeric (FTL) (2) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (2) Washer, Bolt Nut (HTN) (1) Pin, Fixation, Smooth (HTY) (1) Passer (HWQ) (1) Probe (HXB) (1)

Premarket Exempt

No Yes

Clear

n/a - 05060267131508 Catalog Number : n/a

Device Description : SECURE-LOOP 55MM

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

n/a - 05060267131515 Catalog Number : n/a

Device Description : SECURE-LOOP 60MM

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

n/a - 05060267131836 Catalog Number : n/a

Device Description : Infinity-Lock Button System

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : HTN

Prescription Use : Yes

Device Count : 1

Xiros - 05060267131867 Catalog Number : n/a

Device Description : FlexPasser Tendon Retrieval Kit

Device Class : 1

Duns Number: 228209805

Premarket Exempt : Yes

Product Code : HWQ

Prescription Use : Yes

Device Count : 1

Infinity-Lock 3 - 05060267131928 Catalog Number : 102-1100

Device Description : Infinity-Lock 3

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Infinity-Lock 5 - 05060267131935 Catalog Number : 102-1101

Device Description : Infinity-Lock 5

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

SECURE-LOCK - 05060267132000 Catalog Number :

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : GAT, HTY

Prescription Use : Yes

Device Count : 1

Pitch-Patch - 05060267132017 Catalog Number : 102-1090

Device Description : Tissue Reinforcement Device

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Pitch-Patch - 05060267132024 Catalog Number : 102-1091

Device Description : Tissue Reinforcement Device

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Rigid Probe - 05060267132475 Catalog Number :

Device Class : 1

Duns Number: 228209805

Premarket Exempt : Yes

Product Code : HXB

Prescription Use : Yes

Device Count : 1

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