FDA UDI
In Commercial Distribution
🇺🇸 United States
TipVision™
DI: 04250480108802
·
Model: ELEVTV1030
·
SCHÖLLY FIBEROPTIC GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TipVision™
- Primary DI
- 04250480108802
- Version / Model
- ELEVTV1030
- Company Name
- SCHÖLLY FIBEROPTIC GmbH
- Labeler DUNS
- 316276682
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-11
- Public Version
- 1
- Public Version Date
- 2022-01-19
- Public Version Status
- New
- Public Device Record Key
- e469d82e-5111-4aff-a4a4-eb7350e74a72
Device Description
TipVisionTM Videoscope 10x341mm 30° AC
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43053 | Rigid video laparoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250480108802 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal