FDA UDI
In Commercial Distribution
🇺🇸 United States
MediGuide™
DI: 05415067003850
·
Model: DS2M030
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MediGuide™
- Primary DI
- 05415067003850
- Version / Model
- DS2M030
- Catalog Number
- DS2M030
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-29
- Public Version
- 5
- Public Version Date
- 2020-11-30
- Public Version Status
- Update
- Public Device Record Key
- aefe7639-09af-4d81-9666-2ebcadeae1f2
Device Description
GUIDEWIRE TORQUE CLIP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQX | WIRE, GUIDE, CATHETER | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46455 | Torque manipulation device | A sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067003850 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142254 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight. Do not use if package is damaged.
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius