FDA UDI
In Commercial Distribution
🇺🇸 United States
Resectr Resection Device 5FR (1.65 mm)
DI: 00850033976144
·
Model: M0065907051
·
Minerva Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Resectr Resection Device 5FR (1.65 mm)
- Primary DI
- 00850033976144
- Version / Model
- M0065907051
- Catalog Number
- M0065907051
- Company Name
- Minerva Surgical, Inc.
- Labeler DUNS
- 829616478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-03
- Public Version
- 1
- Public Version Date
- 2022-05-11
- Public Version Status
- New
- Public Device Record Key
- 1338732c-35c1-40ed-bc97-871fa3bd244d
Device Description
Resectr Tissue Resection Device 5FR (1.65 mm) (1) Vacuum Tube Adapter
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
- No
- 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 |
|---|---|---|---|---|
| 62952 | Hysteroscopic resection device | A sterile, hand-held, manual surgical instrument intended to be inserted through the working channel of a hysteroscope to cut and remove uterine lesions (e.g., polyps), and may in addition be used to obtain a mucosal biopsy. It consists of a distal cannula with a side-notch and internal oscillating cutting blade, a proximal handle/operating mechanism, and may include a suction port; it does not have a snare mechanism and is not an electrosurgical device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033976144 | GS1 | ||||
| Previous | 08714729964537 | GS1 |
Customer Contacts
- Phone
- 855-646-7874
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French | |
| Outer Diameter | 1.65 | Millimeter |