FDA UDI
In Commercial Distribution
🇺🇸 United States
Benesta Hysteroscope Set
DI: 00857492008041
·
Model: CAL-TR111
·
Caldera Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Benesta Hysteroscope Set
- Primary DI
- 00857492008041
- Version / Model
- CAL-TR111
- Company Name
- Caldera Medical, Inc.
- Labeler DUNS
- 130341956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-03
- Public Version
- 2
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 6cf0cdbe-317a-44f7-9183-87c4489e40cb
Device Description
Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "High-level Disinfectant", "Liquid Chemical"]
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 | 00857492008041 | GS1 |
Customer Contacts
- Phone
- 1-818-879-6555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192822 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.8 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature, in clean and dry location