FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GYNECARE VERSAPOINT
DI: 10705031000940
·
Model: 01936
·
ETHICON INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GYNECARE VERSAPOINT
- Primary DI
- 10705031000940
- Version / Model
- 01936
- Catalog Number
- 01936
- Company Name
- ETHICON INC.
- Labeler DUNS
- 002144145
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- e57ccbcb-4655-4398-bda5-4da372f50463
- Distribution End Date
- 2021-12-15
Device Description
Resectoscopic System, Hysteroscope 4.0mm 30°, Wide Angle
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HIH | HYSTEROSCOPE (AND ACCESSORIES) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36628 | Rigid optical hysteroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705031000940 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care