E-PACK 9811E

GUDID 30705031241842

E-Pack Procedure Kit

ETHICON INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 30705031241842
• NIH Device Record Key: 00ff5af7-b259-4a87-9f98-b21a7c15acda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-PACK
• Version Model Number: 9811E
• Catalog Number: 9811E
• Company DUNS: 002144145
• Company Name: ETHICON 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: true
• 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(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031241845 [Primary]
GS1	30705031241842 [Package]; Contains: 20705031241845; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161726

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

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: 2018-07-06
• Device Publish Date: 2017-11-29

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