Otrieva K-TIVM-172030-US

GUDID 00827002565425

Otrieva, Tapered Ovum Aspiration Needle, Single Lumen

WILLIAM A. COOK AUSTRALIA PTY. LTD.

Body aspiration needle, single-use

• Primary Device ID: 00827002565425
• NIH Device Record Key: 0d95f794-6864-416b-95ab-e42276cf1c6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otrieva
• Version Model Number: G56542
• Catalog Number: K-TIVM-172030-US
• Company DUNS: 758568000
• Company Name: WILLIAM A. COOK AUSTRALIA PTY. LTD.
• 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: true
• 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(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002565425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141365

FDA Product Code

• MQE: NEEDLE, ASSISTED REPRODUCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-24

On-Brand Devices [Otrieva]

• 00827002565425: Otrieva, Tapered Ovum Aspiration Needle, Single Lumen
• 00827002565418: Otrieva, Tapered Ovum Aspiration Needle, Single Lumen