Tornier Perform® Anatomic Augmented Glenoid DWK406RA25S

GUDID 00846832091607

TORNIER, INC.

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• Primary Device ID: 00846832091607
• NIH Device Record Key: 195d1512-e9cb-472a-8ea3-51539f983521
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Perform® Anatomic Augmented Glenoid
• Version Model Number: DWK406RA25S
• Catalog Number: DWK406RA25S
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree
• Device Size Text, specify: 0
• Angle: 25 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832091607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160975

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-21
• Device Publish Date: 2022-04-13

On-Brand Devices [Tornier Perform® Anatomic Augmented Glenoid]

• 00846832092062: DWK405LA25S
• 00846832092048: DWK403LA25S
• 00846832092024: DWK405RA25S
• 00846832091997: DWK405LA15S
• 00846832091980: DWK404LA35S
• 00846832091911: DWK406LA35S
• 00846832091867: DWK405LA35S
• 00846832091850: DWK406RA15S
• 00846832091829: DWK405RA35S
• 00846832091805: DWK403LA15S
• 00846832091799: DWK406LA25S
• 00846832091782: DWK404RA15S
• 00846832091768: DWK403RA35S
• 00846832091737: DWK404LA25S
• 00846832091720: DWK406LA15S
• 00846832091690: DWK404RA35S
• 00846832091676: DWK403LA35S
• 00846832091645: DWK405RA15S
• 00846832091638: DWK406RA35S
• 00846832091607: DWK406RA25S
• 00846832091591: DWK403RA25S
• 00846832091584: DWK404RA25S
• 00846832091553: DWK404LA15S
• 00846832091539: DWK403RA15S
• 00846832091478: DWK403RA35
• 00846832091461: DWK403RA25
• 00846832091454: DWK403LA35
• 00846832091447: DWK403LA25
• 00846832091430: DWK403LA15
• 00846832090785: DWK506RA35
• 00846832090778: DWK506RA25
• 00846832090761: DWK506RA15
• 00846832090754: DWK506LA35
• 00846832090747: DWK506LA25
• 00846832090730: DWK506LA15
• 00846832090723: DWK505RA35
• 00846832090716: DWK505RA25
• 00846832090709: DWK505RA15
• 00846832090693: DWK505LA35
• 00846832090686: DWK505LA25
• 00846832090679: DWK505LA15
• 00846832090662: DWK504RA35
• 00846832090655: DWK504RA25
• 00846832090648: DWK504RA15
• 00846832090631: DWK504LA35
• 00846832090624: DWK504LA25
• 00846832090617: DWK504LA15
• 00846832090600: DWK503RA35
• 00846832090587: DWK503RA15
• 00846832090570: DWK503LA35