Williams 090001-S10

GUDID 00827002152960

Williams Cystoscopic Injection Needle

COOK INCORPORATED

General-purpose endoscopic needle, single-use

• Primary Device ID: 00827002152960
• NIH Device Record Key: afd36818-865d-4cb7-bdea-48e1c494ba67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Williams
• Version Model Number: G15296
• Catalog Number: 090001-S10
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002152960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K812057

FDA Product Code

• FBK: endoscopic injection needle, gastroenterology-urology

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: 2019-09-13
• Device Publish Date: 2016-09-24

On-Brand Devices [Williams]

• 00827002152960: Williams Cystoscopic Injection Needle
• 00827002152762: Williams Cystoscopic Injection Needle
• 00827002142206: Williams Cystoscopic Injection Needle
• 00827002166844: Williams Cystoscopic Injection Needle
• 00827002161122: Williams Cystoscopic Injection Needle
• 00827002162693: Williams Cystoscopic Injection Needle
• 00827002158641: Williams Cystoscopic Injection Needle