TYRX™ Absorbable Antibacterial Envelope - Medium
GUDID 00643169468856
ENVELOPE CMRM6122 ABSORB MED US
MEDTRONIC, INC.
Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| 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.
| 00763000943844 - NA | 2024-04-12 CUSTOM PACK BB11J59R5 PEDS |
| 00763000943851 - NA | 2024-04-12 CUSTOM PACK BB12F35R3 A PACK |
| 00763000943868 - NA | 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT |
| 00763000943899 - NA | 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD |
| 00763000943882 - NA | 2024-04-12 CUSTOM PACK BB12C41R4 10PK LUNG PACK |
| 00763000825539 - NA | 2024-04-08 REV KIT 8598A SPNL SGMNT CATH EMAN |
| 00763000893491 - SHERPA NX BALANCED™ | 2024-04-08 CATHETER SB6CHAMP05SH SB 6F 100CM CH05 |
| 20763000933412 - NA | 2024-04-08 CUSTOM PACK 12F60R 10PK VENTED SPIKE |
Trademark Results [TYRX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYRX 86213023 4736448 Live/Registered |
MEDTRONIC, INC. 2014-03-06 |
 TYRX 76571469 3022471 Live/Registered |
MEDTRONIC, INC. 2004-01-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.