XMCP

GUDID 00842078102602

Lag Screw (solid) - 4.0 x 32 mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078102602
• NIH Device Record Key: b20f8146-3648-44f3-bb70-16360e4844c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XMCP
• Version Model Number: 113-40032
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, LLC
• 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: 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	00842078102602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121417

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078102602]

Moist Heat or Steam Sterilization

[00842078102602]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-05
• Device Publish Date: 2019-06-27

On-Brand Devices [XMCP]

• 00842078108208: Metacarpal Implant - 7.0 x 30 mm (EXTRA-LARGE)
• 00842078108154: Metacarpal Implant - 6.0 x 30 mm (LARGE)
• 00842078108109: Metacarpal Implant - 5.0 x 30 mm (MEDIUM)
• 00842078108055: Small Metacarpal Implant - 4.0mm x 30mm
• 00842078102626: Lag Screw (solid) - 4.0 x 36 mm
• 00842078102619: Lag Screw (solid) - 4.0 x 34 mm
• 00842078102602: Lag Screw (solid) - 4.0 x 32 mm
• 00842078102596: Lag Screw (solid) - 4.0 x 30 mm
• 00842078102589: Lag Screw (solid) - 4.0 x 28 mm
• 00842078102572: Lag Screw (solid) - 4.0 x 26 mm
• 00842078102565: Lag Screw (solid) - 4.0 x 24 mm
• 00842078102558: Lag Screw (solid) - 4.0 x 22 mm
• 00842078102541: Lag Screw (solid) - 4.0 x 20 mm
• 00842078102039: Small Lag Screw - 4.0mm x 36mm
• 00842078102015: Small Lag Screw - 4.0mm x 34mm
• 00842078102008: Small Lag Screw - 4.0mm x 32mm
• 00842078101995: Small Lag Screw - 4.0mm x 30mm
• 00842078101988: Small Lag Screw - 4.0mm x 28mm
• 00842078101971: Small Lag Screw - 4.0mm x 26mm
• 00842078101957: Small Lag Screw - 4.0mm x 24mm
• 00842078101940: Small Lag Screw - 4.0mm x 22mm
• 00842078101933: Small Lag Screw - 4.0mm x 20mm
• 00842078107928: XMCP Instrument Tray