FDA UDI
In Commercial Distribution
🇺🇸 United States
4K UHD Laparoscope
DI: 06971381250183
·
Model: 4K5545
·
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 4K UHD Laparoscope
- Primary DI
- 06971381250183
- Version / Model
- 4K5545
- Company Name
- SCIVITA MEDICAL TECHNOLOGY CO., LTD.
- Labeler DUNS
- 544519831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-17
- Public Version
- 1
- Public Version Date
- 2023-05-25
- Public Version Status
- New
- Public Device Record Key
- e345fa20-9de3-4dd5-ba79-6f0f6b1bdba3
Device Description
These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
| NMH | Laparoscope And Accessories, Gynecologic, Reprocessed | Obstetrics/Gynecology | 884.1720 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12291 | Rigid optical laparoscope | An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971381250180 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 06971381250183 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203255 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- -40 – 55 Degrees Celsius