ANATOMICAL SHOULDER™ FRACTURE

GUDID 00889024386990

Rasp 4.5 [5pf] slim

Zimmer GmbH

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• Primary Device ID: 00889024386990
• NIH Device Record Key: 7ca914cd-1923-43a6-a176-4ca82b21094d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMICAL SHOULDER™ FRACTURE
• Version Model Number: 01.04558.110
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024386990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142403

FDA Product Code

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

Sterilization

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

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

[00889024386990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2016-09-24

On-Brand Devices [ANATOMICAL SHOULDER™ FRACTURE]

• 00889024485686: AS FX Alignment rod
• 00889024485679: AS FX Handle for rasp
• 00889024485662: AS FX Screw for rasp
• 00889024485655: AS FX Spring for rasp
• 00889024287242: AS FX Alignment rod
• 00889024287167: AS FX Handle for rasp
• 00889024287150: AS FX Screw for rasp
• 00889024287136: AS FX Spring for rasp
• 00889024387171: Humeral trial head Ø52 right
• 00889024387164: Humeral trial head Ø52 left
• 00889024387157: Humeral trial head Ø40 right - slim
• 00889024387140: Humeral trial head Ø40 left - slim
• 00889024387133: Humeral trial head Ø36 right - slim
• 00889024387126: Humeral trial head Ø36 left - slim
• 00889024387119: Assembly block / Adapter
• 00889024387102: Rasp extension 18.5 [17ce]
• 00889024387096: Rasp extension 16.5 [17pf/15ce]
• 00889024387089: Rasp 19.5 [18ce]
• 00889024387072: Rasp 18.5 [17ce]
• 00889024387065: Rasp 17.5 [18pf/16ce]
• 00889024387058: Rasp 16.5 [17pf/15ce]
• 00889024387041: Rasp 9.5 [8ce] slim
• 00889024387034: Rasp 8.5 [7ce] slim
• 00889024387027: Rasp 7.5 [8pf/6ce] slim
• 00889024387010: Rasp 6.5 [7pf/5ce] slim
• 00889024387003: Rasp 5.5 [6pf] slim
• 00889024386990: Rasp 4.5 [5pf] slim
• 00889024287365: AS FX Holding Forceps
• 00889024287358: AS FX Control rod
• 00889024287341: AS FX Ruler
• 00889024287310: AS FX Screw for humeral trial head
• 00889024287303: AS FX Humeral trial head, right 48
• 00889024287297: AS FX Humeral trial head, left 48
• 00889024287280: AS FX Humeral trial head, right 44
• 00889024287273: AS FX Humeral trial head, left 44
• 00889024287266: AS FX Humeral trial head, right 40
• 00889024287259: AS FX Humeral trial head, left 40
• 00889024287129: AS FX Rasp 15.5
• 00889024287112: AS FX Rasp extension 14.5
• 00889024287105: AS FX Rasp 14.5
• 00889024287099: AS FX Rasp 13.5
• 00889024287075: AS FX Rasp extension 12.5
• 00889024287068: AS FX Rasp 12.5
• 00889024287044: AS FX Rasp 11.5
• 00889024287013: AS FX Rasp extension 10.5
• 00889024287006: AS FX Rasp 10.5
• 00889024286993: AS FX Rasp 9.5
• 00889024286986: AS FX Rasp extension 8.5
• 00889024286979: AS FX Rasp 8.5
• 00889024286962: AS FX Rasp 7.5