DELTA CTA TIH442

GUDID 10603295265429

DELTA CTA Humeral Head Diameter 42 Height +4mm

DEPUY (IRELAND)

Stem-fixed humeral head prosthesis

• Primary Device ID: 10603295265429
• NIH Device Record Key: 60125d13-e954-46c3-a0dd-0a79935b5951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA CTA
• Version Model Number: TIH442
• Catalog Number: TIH442
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295265429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062116

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-23
• Device Publish Date: 2015-09-24

On-Brand Devices [DELTA CTA]

• 10603295423720: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 42+9mm
• 10603295423713: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 42+6mm
• 10603295423706: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 42+3mm
• 10603295423690: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 42+6mmR
• 10603295423683: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 38+9mm
• 10603295423676: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 38+6mm
• 10603295423669: DELTA CTA Hybrid Humeral Cup Epi 36 Dia 38+3mm
• 10603295285953: DELTA CTA REV TRIAL CUP EPI36 D42 +9mm
• 10603295285946: DELTA CTA REV TRIAL CUP EPI36 D42 +6mm
• 10603295285939: DELTA CTA REV TRIAL CUP EPI36 D42 +3mm
• 10603295285922: DELTA CTA REV TRIAL CUP EPI36 D38 +9mm
• 10603295285915: DELTA CTA REV TRIAL CUP EPI36 D38 +6mm
• 10603295285908: DELTA CTA REV TRIAL CUP EPI36 D38 +3mm
• 10603295285892: DELTA CTA REV RET TRIAL CUP EPI36 D38 +6mm
• 10603295265429: DELTA CTA Humeral Head Diameter 42 Height +4mm
• 10603295265412: DELTA CTA Humeral Head Diameter 36 Height +4mm
• 10603295265405: DELTA CTA Humeral Head Diameter 42 Height 0 mm
• 10603295265399: DELTA CTA Humeral Head Diameter 36 Height 0 mm
• 10603295265160: DELTA CTA HEXAGONAL SCREWDRIVER 2.5 MM
• 10603295265153: DELTA CTA TRIAL HUMERAL HEAD, Diameter 42, +4 MM
• 10603295265146: DELTA CTA TRIAL HUMERAL HEAD, Diameter 36, +4 MM
• 10603295265139: DELTA CTA TRIAL HUMERAL HEAD, Diameter 42, +0 MM
• 10603295265122: DELTA CTA TRIAL HUMERAL HEAD, Diameter 36, +0 MM
• 10603295264095: DELTA CTA Humeral Lengthener, Diameter 42, +9 mm
• 10603295264088: DELTA CTA Humeral Lengthener, Diameter 36, +9 mm
• 10603295264064: DELTA CTA TRIAL HUMERAL LENGTHENER, Diameter 42, +9 MM
• 10603295264057: DELTA CTA TRIAL HUMERAL LENGTHENER, Diameter 36, +9 MM
• 10603295255284: DELTA CTA TRIAL LATERALIZED HUMERAL CUP, Diameter 36, +3 MM
• 10603295255277: DELTA CTA TRIAL LATERALIZED HUMERAL CUP, Diameter 36, +9 MM
• 10603295255260: DELTA CTA TRIAL LATERALIZED HUMERAL CUP, Diameter 42, +3 MM
• 10603295255253: DELTA CTA TRIAL LATERALIZED HUMERAL CUP, Diameter 42, +9 MM
• 10603295170525: DELTA CTA Lateralized Humeral Cup, Diameter 42, +9 mm
• 10603295170518: DELTA CTA Lateralized Humeral Cup, Diameter 36 / +9 mm
• 10603295170501: DELTA CTA Lateralized Retentive Humeral Cup, Diameter 36, +6 mm / R
• 10603295170495: DELTA CTA Lateralized Humeral Cup, Diameter 42, +6 mm / R
• 10603295170488: DELTA CTA Lateralized Retentive Humeral Cup, Diameter 36, +6 mm / R
• 10603295170471: DELTA CTA Lateralized Humeral Cup, Diameter 36, +6 mm
• 10603295170464: DELTA CTA Lateralized Humeral Cup, Diameter 42, +3 mm
• 10603295170457: DELTA CTA Lateralized Humeral Cup, Diameter 36, +3 mm