VARIAX 91-19340

GUDID 07613154353538

DRILL, WL 41MM, AO-SHAFT

Stryker Trauma SA

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 07613154353538
• NIH Device Record Key: f557c16d-7c13-4b76-9a64-df8529c0f35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIAX
• Version Model Number: 91-19340
• Catalog Number: 91-19340
• 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

• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154353538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070876

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [VARIAX]

• 07613327379426: Bone Screw, T5
• 07613327379419: Bone Screw, T5
• 07613327379402: Bone Screw, T5
• 07613327379396: Bone Screw, T5
• 07613327379389: Bone Screw, T5
• 07613327379372: Bone Screw, T5
• 07613327379365: Bone Screw, T5
• 37613327379175: Bone Screw, T6
• 07613327379167: Locking Screw, T6
• 37613327379151: Locking Screw, T6
• 07613327379143: Bone Screw, T5
• 07613327379136: Bone Screw, T6
• 37613327379120: Bone Screw, T5
• 07613327379112: Bone Screw, T5
• 07613327379105: Locking Screw, T6
• 07613327379099: Bone Screw, T6
• 07613327379082: Bone Screw, T6
• 37613327379076: Locking Screw, T6
• 07613327379068: Bone Screw, T6
• 07613327379051: Bone Screw, T6
• 07613327379044: Locking Screw, T6
• 07613327379037: Bone Screw, T5
• 07613327379020: Locking Screw, T6
• 07613327379013: Locking Screw, T6
• 07613327379006: Locking Screw, T6
• 07613327378993: Bone Screw, T6
• 07613327378986: Bone Screw, T6
• 37613327378970: Locking Screw, T6
• 07613327378962: Locking Screw, T5
• 37613327378956: Bone Screw, T5
• 07613327378948: Bone Screw, T6
• 07613327378931: Emerg. Screw, T6
• 07613327378924: Locking Screw, T5
• 07613327378917: Bone Screw, T6
• 07613327378900: Locking Screw, T5
• 07613327378894: Locking Screw, T5
• 07613327378887: Emerg. Screw, T5
• 07613327378870: Bone Screw, T5
• 07613327378863: Emerg. Screw, T5
• 07613327378856: Locking Screw, T5
• 07613327378849: Locking Screw, T5
• 07613327378832: Locking Screw, T5
• 07613327378825: Bone Screw, T6
• 07613327378818: Bone Screw, T6
• 07613327378801: Locking Screw, T5
• 07613327378795: Washer for 1.7mm Bone Screws
• 37613327378789: Locking Screw, T6
• 07613327378771: Emerg. Screw, T6
• 07613327378764: Bone Screw, T5
• 37613327378758: Locking Screw, T6