N/A

GUDID 00889024283268

DURASUL CoCr Head 38/-8 'XS' 12/14

Zimmer GmbH

Metallic femoral head prosthesis

• Primary Device ID: 00889024283268
• NIH Device Record Key: 30f0538a-7a45-4360-89ae-c89fe5f524bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 01.01012.384
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024283268 [Primary]

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-16

On-Brand Devices [N/A]

• 00889024283305: DURASUL CoCr Head 38/+8 'XL' 12/14
• 00889024283299: DURASUL CoCr Head 38/+4 'L' 12/14
• 00889024283282: DURASUL CoCr Head 38/ 0 'M' 12/14
• 00889024283275: DURASUL CoCr Head 38/-4 S 12/14
• 00889024283268: DURASUL CoCr Head 38/-8 'XS' 12/14
• 00889024302907: Gauge for the medullary cavity
• 00889024302884: Awl Cone Prosthesis ø 24
• 00889024302877: Awl Cone Prosthesis ø 23
• 00889024302860: Awl Cone Prosthesis ø 22
• 00889024302853: Awl Cone Prosthesis ø 21
• 00889024302846: Awl Cone Prosthesis ø 20
• 00889024302839: Awl Cone Prosthesis ø 19
• 00889024302822: Awl Cone Prosthesis ø 18
• 00889024302815: Awl Cone Prosthesis ø 17
• 00889024302808: Awl Cone Prosthesis ø 16
• 00889024302792: Awl Cone Prosthesis ø 15
• 00889024302785: Awl Cone Prosthesis ø 14
• 00889024302778: Awl Cone Prosthesis ø 13
• 00889024302761: Impactor Cone Prosthesis
• 00889024298347: Kirschner wire, with trocar tip, ø 2.0 m
• 00889024298330: Kirschner wire, with trocar tip, ø 2.0 m
• 00889024298323: Kirschner wire
• 00889024295629: Locking screw, self-tapping, ø 4.9 mm, 100 mm
• 00889024295605: Locking screw, self-tapping, ø 4.9 mm, 90 mm
• 00889024295575: Locking screw, self-tapping, ø 4.9 mm, 76 mm
• 00889024295568: Locking screw, self-tapping, ø 4.9 mm, 72 mm
• 00889024295551: Locking screw, self-tapping, ø 4.9 mm, 68 mm
• 00889024295513: Locking screw, self-tapping, ø 4.9 mm, 56 mm
• 00889024295490: Locking screw, self-tapping, ø 4.9 mm, 52 mm
• 00889024295483: Locking screw, self-tapping, ø 4.9 mm, 48 mm
• 00889024295476: Locking screw, self-tapping, ø 4.9 mm, 46 mm
• 00889024295452: Locking screw, self-tapping, ø 4.9 mm, 42 mm
• 00889024295438: Locking screw, self-tapping, ø 4.9 mm, 38 mm
• 00889024295421: Locking screw, self-tapping, ø 4.9 mm, 36 mm
• 00889024295407: Locking screw, self-tapping, ø 4.9 mm, 32 mm
• 00889024295391: Locking screw, self-tapping, ø 4.9 mm, 30 mm
• 00889024295384: Locking screw, self-tapping, ø 4.9 mm, 28 mm
• 00889024295377: Locking screw, self-tapping, ø 4.9 mm, 26 mm
• 00889024295360: Locking screw, self-tapping, ø 4.9 mm, 24 mm
• 00889024295353: Cortical screw ø 3.5 self-tapping L.85
• 00889024295346: Cortical screw ø 3.5 self-tapping L.80
• 00889024295339: Cortical screw ø 3.5 self-tapping L.75
• 00889024295322: Cortical screw ø 3.5 self-tapping L.70
• 00889024295315: Cortical screw ø 3.5 self-tapping L.65
• 00889024295308: Cortical screw ø 3.5 self-tapping L.60
• 00889024295292: Cortical screw ø 3.5 self-tapping L.55
• 00889024295285: Cortical screw ø 3.5 self-tapping L.50
• 00889024295278: Cortical screw ø 3.5 self-tapping L.45
• 00889024295261: Cortical screw ø 3.5 self-tapping L.40
• 00889024295254: Cortical screw ø 3.5 self-tapping L.38