TYRX™ Absorbable Antibacterial Envelope - Medium

GUDID 00643169468856

ENVELOPE CMRM6122 ABSORB MED US

MEDTRONIC, INC.

Implantable pulse generator mesh bag, bioabsorbable

• Primary Device ID: 00643169468856
• NIH Device Record Key: 546cfb39-a60d-43a7-b3e2-ca50ff5a0e43
• Commercial Distribution Discontinuation: 2019-09-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TYRX™ Absorbable Antibacterial Envelope - Medium
• Version Model Number: CMRM6122
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169468856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130943

FDA Product Code

• FTL: Mesh, surgical, polymeric

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: 2019-11-08
• Device Publish Date: 2015-06-10

Devices Manufactured by MEDTRONIC, INC.

• 20199150019568 - NA: 2025-05-26 CUSTOM PACK BB11V60R1 20PK VUMC PIGTAILS
• 20199150019582 - NA: 2025-05-26 CUSTOM PACK BB4P07R2 2PK PLEG LIN
• 20199150020717 - NA: 2025-05-26 CUSTOM PACK BB3G62R1 5PK SUPP SUCKR
• 00763000841607 - Cardioblate™ Gemini™-s: 2025-05-26 CLAMP 49351 CARDIOBLATE GEMINI-S FT
• 00199150018154 - NA: 2025-05-23 CUSTOM PACK BB10N41R2 SUPPORT SM
• 00199150019618 - NA: 2025-05-23 CUSTOM PACK BB12Q14R ADULT OXY/TIES
• 00199150019625 - NA: 2025-05-23 CUSTOM PACK BB9N98R17 PUMP PACK
• 00199150019632 - NA: 2025-05-23 CUSTOM PACK BB11P48R5 ATTRNSFN SET