EndoVive One Step Button
- Primary DI
- 08714729284277
- Brand
- EndoVive One Step Button
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M00563150
- Device description
- Low Profile Percutaneous Endoscopic Gastrostomy Kit
- 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
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| KGC | TUBE, GASTRO-ENTEROSTOMY |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729284277 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729284277 | 08714729284277 | 8714729284277 |
GMDN Terms
| Term | Definition |
|---|
| Gastrostomy tube kit, medicated | A collection of devices which includes a gastrostomy tube with a pharmaceutical agent intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy. In addition to the gastrostomy tube and pharmaceutical agent, the kit might also include additional surgical devices (e.g., scalpel, introduction needle, guidewire, dilator, fastener, lubricant). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| 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
- true
- 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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