FDA UDI
In Commercial Distribution
🇺🇸 United States
superDimension
DI: 10884521809567
·
Model: SDMDK1000
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- superDimension
- Primary DI
- 10884521809567
- Version / Model
- SDMDK1000
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- ff4c4133-5133-40dc-80af-917f4b89abdf
Device Description
Marker Delivery Kit
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JAK | System, x-ray, tomography, computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57786 | Bronchoscopic catheter | A sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521809564 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 10884521809567 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 125 | Centimeter | |
| Catheter Gauge | 5 | French | |
| Outer Diameter | 0.038 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry