DYNAMIC COMPRESSION SMA Staple System

GUDID 00885074051444

STAPLE 8162103 3MM X 9MM TWO PRONG SMA

MEDTRONIC SOFAMOR DANEK, INC.

Bone staple

• Primary Device ID: 00885074051444
• NIH Device Record Key: 949f38ed-5605-485c-9d1a-5b8d2c50b824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNAMIC COMPRESSION SMA Staple System
• Version Model Number: 8162103
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074051444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012081

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

Sterilization

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

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

[00885074051444]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-24

On-Brand Devices [DYNAMIC COMPRESSION SMA Staple System]

• 00721902831744: STAPLE 8164614 14MMX15MM 4PRNG SMA
• 00721902831737: STAPLE 8164612 12MMX14MM 4PRNG SMA
• 00721902831713: STAPLE 8164610 10MM X 13MM 4 PRONG SMA
• 00721902831706: STAPLE 8164608 8MM X 12MM 4 PRONG SMA
• 00721902831690: STAPLE 8164606 6MM X 11MM 4 PRONG SMA
• 00721902831683: STAPLE 8164604 4MM X 10MM 4 PRONG SMA
• 00721902671838: STAPLE 8162110 10MM X 13MM 2PRONG SMA
• 00721902671814: STAPLE 8162108 8MM X 12MM 2PRONG SMA
• 00721902671784: STAPLE 8162106 6MM X 11MM 2PRONG SMA
• 00721902662645: STAPLE 8162104 4MM X 10MM 2PRONG SMA
• 00885074423890: 5MM X 10MM SMA 4-PRONG STAPLE
• 00885074051444: STAPLE 8162103 3MM X 9MM TWO PRONG SMA
• 00885074051437: STAPLE 8162102 2MM X 9MM TWO PRONG SMA