Proform Hip System

GUDID 10840843100911

Stelkast Incorporated

Acetabular shell

• Primary Device ID: 10840843100911
• NIH Device Record Key: bd9f056b-bedc-4344-a8c7-9c4469c10569
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proform Hip System
• Version Model Number: SC1408-100-60
• Company DUNS: 804792265
• Company Name: Stelkast Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840843100911 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-02-17

On-Brand Devices [Proform Hip System]

• 10840843108955: 28 MM Hooded Liner
• 10840843108948: 28 MM Hooded Liner
• 10840843108931: 28 MM Hooded Liner
• 10840843108924: 28 MM Hooded Liner
• 10840843108870: 28 MM Hooded Liner
• 10840843108863: 28 MM Hooded Liner
• 10840843108856: 28 MM Hooded Liner
• 10840843108849: 28 MM Non-Hooded Liner
• 10840843108795: 28 MM Non-Hooded Liner
• 10840843108788: 28 MM Non-Hooded Liner
• 10840843108771: 28 MM Non-Hooded Liner
• 10840843108764: 28 MM Non-Hooded Liner
• 10840843106852: 28 MM Non-Hooded Liner
• 10840843106814: 28 MM Non-Hooded Liner
• 10840843106531: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106524: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106517: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106500: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106494: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106487: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106470: 28 MM Hooded Acetabular Liner, PROAR
• 10840843106463: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843106456: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843106449: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843106432: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843106425: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843106418: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843106401: 28 MM Non-Hooded Acetabular Liner, PROAR
• 10840843100065: SC1152-28MM +7
• 10840843100058: SC1152-28MM +12
• 10840843100041: SC1152-28MM +10.5
• 10840843100034: SC1151-28MM -5
• 10840843100027: SC1151-28MM -3.5
• 10840843100010: SC1151-28MM +3.5
• 10840843100003: SC1151-28MM +0
• 10840843101222: SC1408-300-76
• 10840843101215: SC1408-300-74
• 10840843101208: SC1408-300-72
• 10840843101192: SC1408-300-70
• 10840843101185: SC1408-300-68
• 10840843101178: SC1408-300-66
• 10840843101161: SC1408-300-64
• 10840843101154: SC1408-300-62
• 10840843101147: SC1408-300-60
• 10840843101130: SC1408-300-58
• 10840843101123: SC1408-300-56
• 10840843101116: SC1408-300-54
• 10840843101109: SC1408-300-52
• 10840843101093: SC1408-300-50
• 10840843101086: SC1408-300-48