FDA UDI
In Commercial Distribution
🇺🇸 United States
NeedleCam HD System
DI: 00851582006047
·
Model: BVT01197-00001
·
BIOVISION TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NeedleCam HD System
- Primary DI
- 00851582006047
- Version / Model
- BVT01197-00001
- Catalog Number
- BVT01197-00001
- Company Name
- BIOVISION TECHNOLOGIES, LLC
- Labeler DUNS
- 166160106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0262b330-5edf-41b5-9bd1-04c85f8eac9a
Device Description
NeedleCam HD Visualization System
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35616 | Endoscopic video imaging system | An assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851582006047 | GS1 |
Customer Contacts
- Phone
- 303-237-9608
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143705 | 000 |