299961784

GUDID 10603295164661

MAKE TO ORDER GLENOSPHERE ORIENTATION GUIDE LONG

DEPUY ORTHOPAEDICS, INC.

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• Primary Device ID: 10603295164661
• NIH Device Record Key: cd28bf42-2d25-40f1-9275-f7f51019a21a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2999-61-784
• Catalog Number: 299961784
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295164661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170748

FDA Product Code

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

Sterilization

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

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-26
• Device Publish Date: 2021-07-16

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295123132 - MORELAND: 2024-04-03 MORELAND REV INST SCREW TREPHINE REAMER 6.5mm
• 10603295123293 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 11mm 5.5 IN
• 10603295123309 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 12.5mm 5.5 IN
• 10603295123316 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 14mm 5.5 IN
• 10603295123323 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 15.5mm 5.5 IN
• 10603295123330 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 17mm 5.5 IN
• 10603295123347 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 18.5mm 5.5 IN
• 10603295123354 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 11mm 9 IN