FDA UDI
In Commercial Distribution
🇺🇸 United States
SpyScope™ DS II
DI: 08714729965404
·
Model: M00546610
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SpyScope™ DS II
- Primary DI
- 08714729965404
- Version / Model
- M00546610
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-08
- Public Version
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- e919b548-fa35-456a-bb61-1ef87336849c
Device Description
Access and Delivery Catheter
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 |
|---|---|---|---|---|
| FBN | Choledochoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36626 | Flexible video choledochoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). Also known as a cholangioscope, it is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique) or introduced via a flexible duodenoscope during the procedure called choledochoscopy. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end and the images showing on a monitor. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729965404 | GS1 |