M/DN® 00-2253-095-55

GUDID 00889024043862

Zimmer, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00889024043862
• NIH Device Record Key: 4fa7b6cd-d721-4f4e-9fae-16551142dbe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M/DN®
• Version Model Number: 2253-95-55
• Catalog Number: 00-2253-095-55
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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@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
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0
• Length: 95 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024043862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965098

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• NDJ: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-13
• Device Publish Date: 2015-09-24

On-Brand Devices [M/DN®]

• 00889024581791: 2255-26
• 00889024581784: 2255-25
• 00889024046627: 2255-36-80
• 00889024046603: 2255-35-50
• 00889024046597: 2255-34
• 00889024046580: 2255-33-50
• 00889024046573: 2255-33-37
• 00889024046566: 2255-33-32
• 00889024046535: 2255-32-37
• 00889024046528: 2255-31-37
• 00889024046498: 2255-28
• 00889024046481: 2255-27
• 00889024046436: 2255-20
• 00889024046429: 2255-18
• 00889024046405: 2255-16
• 00889024046399: 2255-15-04
• 00889024046382: 2255-15-03
• 00889024046375: 2255-15-02
• 00889024046368: 2255-15-01
• 00889024046344: 2255-14
• 00889024046337: 2255-13-01
• 00889024046320: 2255-13
• 00889024046313: 2255-12-50
• 00889024046306: 2255-12-37
• 00889024046290: 2255-12-33
• 00889024046283: 2255-11
• 00889024046245: 2255-07-50
• 00889024046238: 2255-07-37
• 00889024046221: 2255-06-80
• 00889024046214: 2255-06-37
• 00889024046191: 2255-05-80
• 00889024046184: 2255-05-50
• 00889024046177: 2255-05-32
• 00889024046160: 2255-04-80
• 00889024046153: 2255-04-50
• 00889024046146: 2255-04-32
• 00889024046115: 2255-03-03
• 00889024046061: 2255-02-04
• 00889024046054: 2255-02-02
• 00889024046047: 2255-02-01
• 00889024045873: 2254-300-13
• 00889024045866: 2254-300-12
• 00889024045859: 2254-300-11
• 00889024045842: 2254-300-10
• 00889024045835: 2254-300-09
• 00889024045828: 2254-300-08
• 00889024045811: 2254-300-07
• 00889024045804: 2254-300-06
• 00889024045798: 2254-285-13
• 00889024045781: 2254-285-12