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

Staple, Fixation, Bone (JDR) (3) Bit, Drill (HTW) (2) Hook, Surgical, General & Plastic Surgery (GDG) (1) Staple Driver (HXJ) (1) Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (1) Needle, Suturing, Disposable (GAB) (1) Extractor (HWB) (1)

Premarket Exempt

No Yes

Clear

Neoligaments TM - 05060267130495 Catalog Number : n/a

Device Description : Poly-Tape 20mm x 800mm

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Neoligaments TM - 05060267130501 Catalog Number : n/a

Device Description : Poly-Tape 30mm x 800mm

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

n/a - 05060267130563 Catalog Number : n/a

Device Description : AchilloCordPLUS Poly-Tape

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Neoligaments TM - 05060267130587 Catalog Number : n/a

Device Description : 6mm x 23mm Fastlok plus 2 Ortho-Tapes (3mm x 400mm)

Device Class : 2

Duns Number: 228209805

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Neoligaments TM - 05060267130716 Catalog Number : n/a

Device Description : 20cm Flexible Probe with Eye

Device Class : 1

Duns Number: 228209805

Premarket Exempt : Yes

Product Code : GAB

Prescription Use : Yes

Device Count : 1

n/a - 05060267130785 Catalog Number : n/a

Device Description : Impactor Assembly

Device Class : 1

Duns Number: 228209805

Premarket Exempt : Yes

Product Code : HXJ

Prescription Use : Yes

Device Count : 1

Neoligaments TM - 05060267130853 Catalog Number : n/a

Device Description : 9mm Reamer Bit - Sterile

Device Class : 1

Duns Number: 228209805

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Neoligaments TM - 05060267130860 Catalog Number : n/a

Device Description : 10mm Reamer Bit - Sterile

Device Class : 1

Duns Number: 228209805

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

n/a - 05060267130884 Catalog Number : n/a

Device Description : Sliding Hammer

Device Class : 1

Duns Number: 228209805

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

n/a - 05060267131355 Catalog Number : n/a

Device Description : CC-Hook Left

Device Class : 1

Duns Number: 228209805

Premarket Exempt : No

Product Code : GDG

Prescription Use : Yes

Device Count : 1

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