OMEGA 3362-5-100

GUDID 07613327092875

Standard Lag Screw

Stryker Trauma SA

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 07613327092875
• NIH Device Record Key: 6cfc5641-b899-4b72-bce6-b94e61317da2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMEGA
• Version Model Number: 3362-5-100
• Catalog Number: 3362-5-100
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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

Device Dimensions

• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327092875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955306

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [OMEGA]

• 07613327093247: Std Barrel Sideplate; Keyless
• 07613327093230: Std Barrel Sideplate; Keyless
• 07613327093223: Std Barrel Sideplate; Keyless
• 07613327093216: Std Barrel Sideplate; Keyless
• 07613327093209: Std Barrel Sideplate; Keyless
• 07613327093193: Std Barrel Sideplate; Keyless
• 07613327093186: Std Barrel Sideplate; Keyless
• 07613327093179: Std Barrel Sideplate; Keyless
• 07613327093162: Std Barrel Sideplate; Keyless
• 07613327093155: Std Barrel Sideplate; Keyless
• 07613327093148: Std Barrel Sideplate; Keyless
• 07613327093131: Std Barrel Sideplate; Keyless
• 07613327093124: Std Barrel Sideplate; Keyless
• 07613327093117: Std Barrel Sideplate; Keyless
• 07613327093100: Std Barrel Sideplate; Keyless
• 07613327093094: Std Barrel Sideplate; Keyless
• 07613327093087: Std Barrel Sideplate; Keyless
• 07613327093070: Std Barrel Sideplate; Keyless
• 07613327093063: Std Barrel Sideplate; Keyless
• 07613327093032: Standard Lag Screw
• 07613327093025: Standard Lag Screw
• 07613327093018: Standard Lag Screw
• 07613327093001: Standard Lag Screw
• 07613327092998: Standard Lag Screw
• 07613327092981: Standard Lag Screw
• 07613327092974: Standard Lag Screw
• 07613327092967: Standard Lag Screw
• 07613327092950: Standard Lag Screw
• 07613327092943: Standard Lag Screw
• 07613327092936: Standard Lag Screw
• 07613327092929: Standard Lag Screw
• 07613327092912: Standard Lag Screw
• 07613327092905: Standard Lag Screw
• 07613327092899: Standard Lag Screw
• 07613327092882: Standard Lag Screw
• 07613327092875: Standard Lag Screw
• 07613327092868: Standard Barrel Sideplate
• 07613327092851: Standard Barrel Sideplate
• 07613327092844: Standard Barrel Sideplate
• 07613327092837: Standard Barrel Sideplate
• 07613327092820: Standard Barrel Sideplate
• 07613327092813: Standard Barrel Sideplate
• 07613327092806: Standard Barrel Sideplate
• 07613327092790: Standard Barrel Sideplate
• 07613327092783: Standard Barrel Sideplate
• 07613327092776: Standard Barrel Sideplate
• 07613327092769: Standard Barrel Sideplate
• 07613327092752: Standard Barrel Sideplate
• 07613327092745: Standard Barrel Sideplate
• 07613327092738: Standard Barrel Sideplate