FDA UDI
In Commercial Distribution
🇺🇸 United States
Benesta Tissue Removal Device
DI: 00857492008096
·
Model: CAL-TR1511
·
Caldera Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Benesta Tissue Removal Device
- Primary DI
- 00857492008096
- Version / Model
- CAL-TR1511
- Company Name
- Caldera Medical, Inc.
- Labeler DUNS
- 130341956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-18
- Public Version
- 1
- Public Version Date
- 2022-07-26
- Public Version Status
- New
- Public Device Record Key
- 39430817-bc22-4cd5-9e24-3c1905ed4a21
Device Description
The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 64199 | Tissue morcellation system handpiece, battery-powered | A battery-powered, hand-held device intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery (e.g., prostate tissue morcellation during laparoscopy). It consists of a cordless instrument with a high-speed rotating blade in a holder. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00857492008102 | GS1 | Box | 3 | In Commercial Distribution | |
| Primary | 00857492008096 | GS1 |
Customer Contacts
- Phone
- 1-818-879-6555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192811 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature, in a clean, dry location