NA
- Primary DI
- 08714729005322
- Brand
- NA
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M0062401000
- Device description
- Ureteral Dilatation System
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| EZN | DILATOR, CATHETER, URETERAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EZN | Dilator, Catheter, Ureteral | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729005322 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729005322 | 08714729005322 | 8714729005322 |
GMDN Terms
| Term | Definition |
|---|
| Endoscopic-access dilator, single-use | A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00827002150102 | Cook 810 | COOK INCORPORATED | EZN | 2019-11-27 |