CG FUTURE™
GUDID 00643169793576
RING 638RL38 CG FUTURE ANNULO 29L
MEDTRONIC, INC.
Mitral annuloplasty ring| Primary Device ID | 00643169793576 |
| NIH Device Record Key | b61ec66e-e231-4455-845b-a575190ec476 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CG FUTURE™ |
| Version Model Number | 638RL38 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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
Device Dimensions
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
| Lumen/Inner Diameter | 38 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169793576 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061127
FDA Product Code
| KRH | RING, ANNULOPLASTY |
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 | 2019-08-12 |
| Device Publish Date | 2017-10-29 |
On-Brand Devices [CG FUTURE™]
| 00643169793644 | BAND 638BL38 CG FUTURE ANULO 29L |
| 00643169793637 | BAND 638BL36 CG FUTURE ANULO 29L |
| 00643169793620 | BAND 638BL34 CG FUTURE ANULO 29L |
| 00643169793613 | BAND 638BL32 CG FUTURE ANULO 29L |
| 00643169793606 | BAND 638BL30 CG FUTURE ANULO 29L |
| 00643169793590 | BAND 638BL28 CG FUTURE ANULO 29L |
| 00643169793583 | BAND 638BL26 CG FUTURE ANULO 29L |
| 00643169793576 | RING 638RL38 CG FUTURE ANNULO 29L |
| 00643169793569 | RING 638RL36 CG FUTURE ANNULO 29L |
| 00643169793552 | RING 638RL34 CG FUTURE ANNULO 29L |
| 00643169793545 | RING 638RL32 CG FUTURE ANNULO 29L |
| 00643169793538 | RING 638RL30 CG FUTURE ANNULO 29L |
| 00643169793521 | RING 638RL28 CG FUTURE ANNULO 29L |
| 00643169793514 | RING 638RL26 CG FUTURE ANNULO 29L |
| 00643169793507 | RING 638RL24 CG FUTURE ANNULO 29L |
Trademark Results [CG FUTURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CG FUTURE 78656680 3326339 Live/Registered |
Medtronic, Inc. 2005-06-23 |
 CG FUTURE 78121917 2949561 Live/Registered |
MEDTRONIC INC. 2002-04-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.