Tornier Perform® Reversed Glenoid DWJ350

GUDID 00846832088621

TORNIER, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00846832088621
• NIH Device Record Key: 0eb6d400-6c67-4e10-a976-9b7001248345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Perform® Reversed Glenoid
• Version Model Number: DWJ350
• Catalog Number: DWJ350
• 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: true
• Serial Number: false
• 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
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• Email: customerservice@tornier.com
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• 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
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• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com
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• 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
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• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com
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• Email: customerservice@tornier.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832088621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161742

FDA Product Code

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

Sterilization

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

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

[00846832088621]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-03
• Device Publish Date: 2022-04-25

On-Brand Devices [Tornier Perform® Reversed Glenoid]

• 00846832091423: DWJ754
• 00846832091300: DWJ750
• 00846832091294: DWJ746
• 00846832091287: DWJ742
• 00846832091270: DWJ738
• 00846832091263: DWJ734
• 00846832091256: DWJ730
• 00846832091249: DWJ726
• 00846832091232: DWJ722
• 00846832091225: DWJ718
• 00846832091218: DWJ714
• 00846832091201: DWJ650
• 00846832091195: DWJ645
• 00846832091188: DWJ640
• 00846832091171: DWJ635
• 00846832091164: DWJ630
• 00846832091157: DWJ625
• 00846832091140: DWJ550
• 00846832091133: DWJ545
• 00846832091126: DWJ540
• 00846832091119: DWJ535
• 00846832091102: DWJ530
• 00846832091096: DWJ525
• 00846832090426: DWJ034
• 00846832090419: DWJ033
• 00846832090402: DWJ032
• 00846832090396: DWJ024
• 00846832090389: DWJ023
• 00846832090372: DWJ022
• 00846832090365: DWJ021
• 00846832090358: DWJ014
• 00846832090341: DWJ013
• 00846832090334: DWJ012
• 00846832090242: DWJ125
• 00846832090211: DWJ245
• 00846832090051: DWJ322
• 00846832090037: DWJ235
• 00846832089895: DWJ140
• 00846832089819: DWJ346
• 00846832089796: DWJ145
• 00846832089697: DWJ334
• 00846832089574: DWJ314
• 00846832089543: DWJ130
• 00846832089468: DWJ318
• 00846832089406: DWJ330
• 00846832089383: DWJ250
• 00846832089307: DWJ338
• 00846832089284: DWJ135
• 00846832088904: DWJ342
• 00846832088881: DWJ225