FDA UDI
In Commercial Distribution
🇺🇸 United States
IN.PACT™ Admiral™
DI: 00643169383340
·
Model: ADM07004013P
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IN.PACT™ Admiral™
- Primary DI
- 00643169383340
- Version / Model
- ADM07004013P
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-01-29
- Public Version
- 6
- Public Version Date
- 2021-05-27
- Public Version Status
- Update
- Public Device Record Key
- 35d7873e-95e1-463f-860f-1821d29dc007
Device Description
DEB ADM07004013P 07.00 L040 UL1300 US
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62551 | Peripheral angioplasty balloon catheter, drug-coated | A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169383340 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140010 | 000 |
| P140010 | 006 |
| P140010 | 009 |
| P140010 | 015 |
| P140010 | 017 |
| P140010 | 023 |
| P140010 | 032 |
| P140010 | 037 |
| P140010 | 043 |
| P140010 | 050 |
| P140010 | 051 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Balloon Diameter 7 MM | ||
| Device Size Text, specify | Balloon Length 40 MM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the device in the original container.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius