FDA UDI
In Commercial Distribution
🇺🇸 United States
ColpoWave Colpotomizer
DI: 09351599000324
·
Model: CWD
·
SURGITOOLS PTY. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ColpoWave Colpotomizer
- Primary DI
- 09351599000324
- Version / Model
- CWD
- Company Name
- SURGITOOLS PTY. LTD.
- Labeler DUNS
- 745798822
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d9687ab5-4a00-4f82-b9b9-afbac6691563
Device Description
ColpoWave Colpotomizer box containing 6 sterile units
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
- Yes
- 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 |
|---|---|---|---|---|
| HEW | Culdoscope (And Accessories) | Obstetrics/Gynecology | 884.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47936 | Colpotomy tube | A sterile, hand-held, hollow cylindrical device designed to facilitate dissection of the cervical/vaginal junction during total laparoscopic-assisted hysterectomy. It is typically made of plastic material and functions as a transvaginal conduit for surgical instruments and as an anvil-like support during dissection. Its distal end is designed to fit tightly against the cervix, and its proximal end has a seal to prevent loss of peritoneum-distention gas [e.g., carbon dioxide (CO2)] used during the laparoscopic procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09351599000324 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161065 | 000 |