Getinge Pack Tyvek Roll 61301606732

GUDID 10850144008083

Tyvek Roll 05cm x 30m

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use

• Primary Device ID: 10850144008083
• NIH Device Record Key: baa3c9aa-cfbe-45ea-9d01-21ca593f1134
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge Pack Tyvek Roll
• Version Model Number: GUTY0530
• Catalog Number: 61301606732
• Company DUNS: 565751992
• Company Name: PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 4196935300
• Email: rdean@lexamed.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850144008086 [Primary]
GS1	10850144008083 [Package]; Contains: 00850144008086; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160595

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-09-10

On-Brand Devices [Getinge Pack Tyvek Roll]

• 10850144008120: Tyvek Roll 25cm x 30m
• 00850144008116: Tyvek Roll 20cm x 30m
• 00850144008109: Tyvek Roll 15cm x 30m
• 00850144008093: Tyvek Roll 10cm x 30m
• 10850144008083: Tyvek Roll 05cm x 30m