FDA UDI
In Commercial Distribution
🇺🇸 United States
Video Camera Insert
DI: 00878953005553
·
Model: 0010-0721
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Video Camera Insert
- Primary DI
- 00878953005553
- Version / Model
- 0010-0721
- Catalog Number
- 0010-0721
- 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
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- eec14e52-8ac4-40aa-8ced-f8ca0c81ccbf
Device Description
Video Camera Insert - For Rigid Endoscopes
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36308 | Operator eye protection laser filter | An eyepiece intended to be fitted to a device used during a laser procedure (e.g., surgical laser system, endoscope, surgical microscope) to protect the operator's eyes from laser energy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00878953005553 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1.25 Inch Diameter |