Delta Cup 9051.10.033

GUDID 08033390117692

Head Pusher

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390117692
• NIH Device Record Key: 8eb8e6e3-4287-48a6-8516-5fe6962cfc6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Cup
• Version Model Number: 9051.10.033
• Catalog Number: 9051.10.033
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390117692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181491

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

[08033390117692]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-03
• Device Publish Date: 2019-06-25

On-Brand Devices [Delta Cup]

• 08033390117722: Neck Positioner for Press
• 08033390117715: Double Mobility Press
• 08033390117692: Head Pusher
• 08033390062817: Trial Liner #M for Dual Mobility Dia. 40 mm
• 08033390062183: Trial Mobile Liner Dia. 42 mm for Head Dia. 28 mm
• 08033390059794: Trial Mobile Liner Dia. 40 mm for Head Dia. 28 mm
• 08033390059763: Trial Liner #L for Dual Mobility Dia. 42 mm
• 08033390071857: Curved Impactor
• 08033390058896: Curved Impactor
• 08033390058889: Adapter Large for Curved Impactor
• 08033390058858: Adapter Medium for Curved Impactor
• 08033390058469: Adapter Small for Curved Impactor