Ascend™

GUDID 00846832004393

TORNIER, INC.

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00846832004393
• NIH Device Record Key: fefa082b-fa57-42e5-be9e-5242a74cca13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascend™
• Version Model Number: 503301A
• Company DUNS: 968990812
• Company Name: TORNIER, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

• Length: 66 Millimeter
• Length: 66 Millimeter
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 66 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832004393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120794

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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: 2015-10-16

On-Brand Devices [Ascend™]

• 00846832004652: 503309C
• 00846832004645: 503309B
• 00846832004638: 503309A
• 00846832004621: 503308C
• 00846832004614: 503308B
• 00846832004607: 503308A
• 00846832004591: 503307C
• 00846832004584: 503307B
• 00846832004577: 503307A
• 00846832004560: 503306C
• 00846832004553: 503306B
• 00846832004546: 503306A
• 00846832004539: 503305C
• 00846832004522: 503305B
• 00846832004515: 503305A
• 00846832004508: 503304C
• 00846832004492: 503304B
• 00846832004485: 503304A
• 00846832004478: 503303C
• 00846832004461: 503303B
• 00846832004454: 503303A
• 00846832004447: 503302C
• 00846832004430: 503302B
• 00846832004423: 503302A
• 00846832004416: 503301C
• 00846832004409: 503301B
• 00846832004393: 503301A
• 00846832004386: 502454
• 00846832004362: 502452
• 00846832004348: 502450
• 00846832004324: 502448
• 00846832004300: 502446
• 00846832004287: 502444
• 00846832004263: 502442
• 00846832004249: 502440
• 00846832004225: 502438
• 00846832004201: 502354
• 00846832004188: 502352
• 00846832004164: 502350
• 00846832004140: 502348
• 00846832004126: 502346
• 00846832004102: 502344
• 00846832004089: 502342
• 00846832004065: 502340
• 00846832004041: 502338