FDA UDI
Not in Commercial Distribution
🇺🇸 United States
INDURA®
DI: 00613994586056
·
Model: 8709SC
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INDURA®
- Primary DI
- 00613994586056
- Version / Model
- 8709SC
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- de40e600-ecb3-47a9-befe-99c57d42b3a8
- Distribution End Date
- 2017-03-06
Device Description
CATH 8709SC 1PC SUTURLESS US (TRAY)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35687 | General-purpose implantable infusion pump, programmable | A battery-powered, sterile device designed to be implanted in a patient for the long-term or intermittent infusion of narcotics, short-acting anaesthetic agents, antineoplastic drugs, and other agents. This implantable infusion pump (IIP) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. A catheter connected to the reservoir is inserted into the epidural or subarachnoid (intrathecal) space of the spinal canal or into a blood vessel. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994586056 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860004 | 128 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 81.4 | Centimeter |