Capsure® VDD-2
GUDID 00613994250155
LEAD-5038S-52,US FPA 52CM PASS QUAD SIL
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00613994250155 |
| NIH Device Record Key | 85d7ffda-bcfe-4b22-bc96-c47e68d0ebce |
| Commercial Distribution Discontinuation | 2018-06-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Capsure® VDD-2 |
| Version Model Number | 5038S-52 |
| 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 | 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
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994250155 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P890003
FDA Product Code
| DTB | permanent pacemaker Electrode |
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 | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [Capsure® VDD-2]
| 00613994250155 | LEAD-5038S-52,US FPA 52CM PASS QUAD SIL |
| 00613994250148 | LEAD 5038S-58 US FPA PASS QUAD SILIC |
| 00643169325715 | LEAD 5038S-58 USA NO SILACURE |
| 00643169325708 | LEAD 5038S-52 USA NO SILACURE |
| 00643169325692 | LEAD 5038L-65 USA NO SILACURE |
| 00643169325685 | LEAD 5038-65 USA NO SILACURE |
| 00643169325678 | LEAD 5038-58 USA NO SILACURE |
| 00681490122931 | LEAD 5038S-58 QUAD SNGL-P A/V 11.5CM US |
| 00681490122832 | LEAD 5038S-52 QUAD SNGL-P A/V 11.5CM US |
| 00681490122733 | LEAD 5038L-65 QUAD SNGL-P A/V 15.5CM US |
| 00885074201573 | LEAD 5038-65 CAPSURE VDD2 PACING US |
| 00885074201566 | LEAD 5038-58 CAPSURE VDD2 PACING US |
Trademark Results [Capsure]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.