FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04048551227299
·
Model: 11630AA
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04048551227299
- Version / Model
- 11630AA
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 07254e5d-6ff4-4770-bc95-3ae0901e4890
Device Description
Mini Straight-Forward Telescope 0°,2 mm
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", "Hydrogen Peroxide", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HFA | Amnioscope, Transabdominal (Fetoscope) (And Accessories) | Obstetrics/Gynecology | 884.1600 | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37152 | Flexible fibreoptic hysteroscope | An endoscope with a flexible 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 by the device through a fibreoptic bundle. Distention of the uterus with either liquid or carbon dioxide (CO2) gas may be used to improve viewing. This device is commonly 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 | 04048551227299 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 2 | Millimeter | |
| Length | 30 | Centimeter |