FDA UDI
In Commercial Distribution
🇺🇸 United States
CAPTIVATOR II
DI: 08714729861324
·
Model: M00561230
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- CAPTIVATOR II
- Primary DI
- 08714729861324
- Version / Model
- M00561230
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3e599f48-e19b-4583-8484-d699e81237a1
Device Description
Single-Use Polypectomy Snare
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 |
|---|---|---|---|---|
| FDI | SNARE, FLEXIBLE | Gastroenterology, Urology | 876.4300 | 2 |
| FGX | SNARE, NON-ELECTRICAL | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35622 | Flexible polypectomy snare, single-use | A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729855910 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08714729861324 | GS1 | ||||
| Package | 08714729861348 | GS1 | 40 | In Commercial Distribution | ||
| Package | 08714729861331 | GS1 | 20 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 mm Diameter |