DEPUY (IRELAND)

Address:LOUGHBEG,CO. CORK Munster,IE

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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

TEMPLATE (HWT) (3) REAMER (HTO) (3) Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment (KIJ) (2) PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED (KWT) (1) PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED (KWS) (1) PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED (MBF) (1) RASP (HTR) (1) prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented (PAO) (1) DRIVER, PROSTHESIS (HWR) (1) shoulder prosthesis, reverse configuration (PHX) (1) Orthopedic manual surgical instrument (LXH) (1) PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED (HSD) (1)

Premarket Exempt

No Yes

Clear

INHANCE - 10603295547570 Catalog Number : 650540008

Device Description : INHANCE SHOULDER SYSTEM GLENOSPHERE TRIAL Ø40 +8mm

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

INHANCE - 10603295547587 Catalog Number : 650540108

Device Description : INHANCE SHOULDER SYSTEM GLENOSPHERE TRIAL ECCENTRIC Ø40 +8mm

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

INHANCE - 10603295547594 Catalog Number : 650530100

Device Description : INHANCE SHOULDER SYSTEM GLENOSPHERE TRIAL SCREW

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

INHANCE - 10603295547600 Catalog Number : 650311500

Device Description : INHANCE SHOULDER SYSTEM PERIPHERAL REAMER LARGE

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : No

Device Count : 1

INHANCE - 10603295547617 Catalog Number : 650311300

Device Description : INHANCE SHOULDER SYSTEM PERIPHERAL REAMER SMALL

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : No

Device Count : 1

INHANCE - 10603295547624 Catalog Number : 650311108

Device Description : INHANCE SHOULDER SYSTEM PERIPHERAL SCREW DRILL GUIDE

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : MBF, HSD, KWS, KWT, PAO, PHX

Prescription Use : No

Device Count : 1

INHANCE - 10603295547631 Catalog Number : 650510103

Device Description : INHANCE SHOULDER SYSTEM STAR DRIVER 20

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : KIJ, HWR

Prescription Use : No

Device Count : 1

INHANCE - 10603295547679 Catalog Number : 750510105

Device Description : INHANCE SHOULDER SYSTEM PERIPHERAL SCREW DRILL Ø3.2mm X 250mm

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : KIJ, HTO

Prescription Use : No

Device Count : 1

INTUITION - 10603295547860 Catalog Number : 252545005

Device Description : INTUITION FOR HP PARTIAL PIN PACK

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

INTUITION - 10603295547884 Catalog Number : 252545006

Device Description : INTUITION FOR HP PARTIAL TIBIAL KEEL RASP

Device Class : 1

Duns Number: 989365556

Premarket Exempt : Yes

Product Code : HTR

Prescription Use : No

Device Count : 1

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