Stratum Ankle

GUDID 00810082890426

Stratum Ankle Locking Screw Non-Sterile 3.5mmX32mm

Medartis Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810082890426
• NIH Device Record Key: 99d18d1e-710b-4039-8645-3fc54208c244
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratum Ankle
• Version Model Number: SALS3532NS
• Company DUNS: 192756786
• Company Name: Medartis Inc.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810082890426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212640

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

[00810082890426]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-05
• Device Publish Date: 2023-05-26

On-Brand Devices [Stratum Ankle]

• 00810082897999: Stratum Ankle Crossing Screw Instrument Case Lid
• 00810082890105: Stratum Ankle Locking Screw Sterile 3.5mmX30mm
• 00810082890099: Stratum Ankle Locking Screw Sterile 3.5mmX28mm
• 00810082890082: Stratum Ankle Locking Screw Sterile 3.5mmX26mm
• 00810082890075: Stratum Ankle Locking Screw Sterile 3.5mmX24mm
• 00810082890068: Stratum Ankle Locking Screw Sterile 3.5mmX22mm
• 00810082890051: Stratum Ankle Locking Screw Sterile 3.5mmX20mm
• 00810082890044: Stratum Ankle Locking Screw Sterile 3.5mmX18mm
• 00810082890037: Stratum Ankle Locking Screw Sterile 3.5mmX16mm
• 00810082890020: Stratum Ankle Locking Screw Sterile 3.5mmX14mm
• 00810082890013: Stratum Ankle Locking Screw Sterile 3.5mmX12mm
• 00810082890006: Stratum Ankle Locking Screw Sterile 3.5mmX10mm
• 00810082897982: Stratum Ankle Crossing Screw Instrument Case Tray
• 00810082897975: Stratum Ankle Screw Caddy Case Lid
• 00810082897968: Stratum Ankle Screw Caddy Case
• 00810082897951: Stratum Ankle Screw Caddy Lid
• 00810082897944: Stratum Ankle Screw Caddy
• 00810082897937: Stratum Ankle Instrument Case Lid
• 00810082897920: Stratum Ankle Instrument Case Inner Tray
• 00810082897913: Stratum Ankle Instrument Case Tray
• 00810082896916: Stratum Ankle Non-Locking Screw Non-Sterile 5.0mmX80mm
• 00810082896909: Stratum Ankle Non-Locking Screw Non-Sterile 5.0mmX78mm
• 00810082896893: Stratum Ankle Non-Locking Screw Non-Sterile 5.0mmX76mm
• 00810082896886: Stratum Ankle Non-Locking Screw Non-Sterile 5.0mmX74mm
• 00810082896879: Stratum Ankle Non-Locking Screw Non-Sterile 5.0mmX72mm
• 00810082896862: Stratum Ankle Non-Locking Screw Sterile 5.0mmX80mm
• 00810082896855: Stratum Ankle Non-Locking Screw Sterile 5.0mmX78mm
• 00810082896848: Stratum Ankle Non-Locking Screw Sterile 5.0mmX76mm
• 00810082896831: Stratum Ankle Non-Locking Screw Sterile 5.0mmX74mm
• 00810082896824: Stratum Ankle Non-Locking Screw Sterile 5.0mmX72mm
• 00810082896817: Stratum Ankle Non-Locking Screw Non-Sterile 3.5mmX80mm
• 00810082896800: Stratum Ankle Non-Locking Screw Non-Sterile 3.5mmX78mm
• 00810082896794: Stratum Ankle Non-Locking Screw Non-Sterile 3.5mmX76mm
• 00810082896787: Stratum Ankle Non-Locking Screw Non-Sterile 3.5mmX74mm
• 00810082896770: Stratum Ankle Non-Locking Screw Non-Sterile 3.5mmX72mm
• 00810082896763: Stratum Ankle Non-Locking Screw Sterile 3.5mmX80mm
• 00810082896756: Stratum Ankle Non-Locking Screw Sterile 3.5mmX78mm
• 00810082896749: Stratum Ankle Non-Locking Screw Sterile 3.5mmX76mm
• 00810082896732: Stratum Ankle Non-Locking Screw Sterile 3.5mmX74mm
• 00810082896725: Stratum Ankle Non-Locking Screw Sterile 3.5mmX72mm
• 00810082896718: Stratum Ankle Locking Screw Non-Sterile 5.0mmX80mm
• 00810082896701: Stratum Ankle Locking Screw Non-Sterile 5.0mmX78mm
• 00810082896695: Stratum Ankle Locking Screw Non-Sterile 5.0mmX76mm
• 00810082896688: Stratum Ankle Locking Screw Non-Sterile 5.0mmX74mm
• 00810082896671: Stratum Ankle Locking Screw Non-Sterile 5.0mmX72mm
• 00810082896664: Stratum Ankle Locking Screw Sterile 5.0mmX80mm
• 00810082896657: Stratum Ankle Locking Screw Sterile 5.0mmX78mm
• 00810082896640: Stratum Ankle Locking Screw Sterile 5.0mmX76mm
• 00810082896633: Stratum Ankle Locking Screw Sterile 5.0mmX74mm
• 00810082896626: Stratum Ankle Locking Screw Sterile 5.0mmX72mm