TYRX™ Absorbable Antibacterial Envelope - Large
GUDID 00643169468795
ENVELOPE CMRM6133 ABSORB LRG US
MEDTRONIC, INC.
Implantable pulse generator mesh bag, bioabsorbable| Primary Device ID | 00643169468795 |
| NIH Device Record Key | ebe9e38e-9c4c-49c4-bddc-f5b0b7dfea34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TYRX™ Absorbable Antibacterial Envelope - Large |
| Version Model Number | CMRM6133 |
| 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 | 00643169468795 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-10 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000893910 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40 |
| 00763000893941 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40 |
| 00763000988258 - NA | 2024-12-20 CUSTOM PACK BB10Q85R1 FILTER |
| 00763000988760 - NA | 2024-12-20 CUSTOM PACK BB1F66R26 CASPER |
| 00763000973391 - Sphere-9™ Catheter | 2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR |
| 00763000986704 - NA | 2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC |
| 00763000986773 - NA | 2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK |
| 20763000986814 - NA | 2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES |
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 |
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