FDA UDI
In Commercial Distribution
🇺🇸 United States
CinchPad™
DI: 00816849010045
·
Model: SPX-017-25
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- CinchPad™
- Primary DI
- 00816849010045
- Version / Model
- SPX-017-25
- Catalog Number
- SPX-017-25
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-01-11
- Public Version
- 1
- Public Version Date
- 2019-02-11
- Public Version Status
- New
- Public Device Record Key
- f14591c7-087f-4a73-a48a-cb82f54852ff
Device Description
Endoscope Transport
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KME | BEDDING, DISPOSABLE, MEDICAL | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64018 | Instrument hygienic-transportation bag | A non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816849010045 | GS1 | ||||
| Unit of Use | 08714729989561 | GS1 |