ITST® 00-2253-065-45

GUDID 00889024043435

Zimmer, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00889024043435
• NIH Device Record Key: 18b2f78d-252b-4c09-99ec-80fd7f87329e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITST®
• Version Model Number: 2253-65-45
• Catalog Number: 00-2253-065-45
• Company DUNS: 056038268
• Company Name: Zimmer, 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: 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

Device Dimensions

• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024043435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143321

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
• 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: 2015-09-17

On-Brand Devices [ITST®]

• 00889024043831: 2253-90-45
• 00889024043794: 2253-87-45
• 00889024043756: 2253-85-45
• 00889024043718: 2253-82-45
• 00889024043671: 2253-80-45
• 00889024043633: 2253-77-45
• 00889024043596: 2253-75-45
• 00889024043558: 2253-72-45
• 00889024043510: 2253-70-45
• 00889024043473: 2253-67-45
• 00889024043435: 2253-65-45
• 00889024043398: 2253-62-45
• 00889024043350: 2253-60-45
• 00889024043312: 2253-57-45
• 00889024043275: 2253-55-45
• 00889024043237: 2253-52-45
• 00889024043190: 2253-50-45
• 00889024043152: 2253-47-45
• 00889024043114: 2253-45-45
• 00889024043077: 2253-42-45
• 00889024043039: 2253-40-45
• 00889024042995: 2253-37-45
• 00889024042957: 2253-35-45
• 00889024042919: 2253-32-45
• 00889024042872: 2253-30-45
• 00889024042834: 2253-27-45
• 00889024042797: 2253-25-45
• 00889024042759: 2253-22-45
• 00889024042711: 2253-20-45
• 00889024049222: 2259-09-20
• 00889024049215: 2259-09-15
• 00889024049208: 2259-09-10
• 00889024049192: 2259-09-05
• 00889024049185: 2259-09
• 00889024049178: 2259-08-20
• 00889024049161: 2259-08-15
• 00889024049154: 2259-08-10
• 00889024049147: 2259-08-05
• 00889024049130: 2259-08
• 00889024049123: 2259-07-20
• 00889024049116: 2259-07-15
• 00889024049109: 2259-07-10
• 00889024049093: 2259-07-05
• 00889024049086: 2259-07
• 00889024049079: 2259-01-52
• 00889024049062: 2259-01-50
• 00889024049055: 2259-01-47
• 00889024049048: 2259-01-45
• 00889024049031: 2259-01-42
• 00889024049024: 2259-01-40