FDA UDI
In Commercial Distribution
🇺🇸 United States
THD SLIDE ONE
DI: 18033737710354
·
Model: THD DOPPLER PROBE (1s/ST)
·
THD SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- THD SLIDE ONE
- Primary DI
- 18033737710354
- Version / Model
- THD DOPPLER PROBE (1s/ST)
- Catalog Number
- 800063
- Company Name
- THD SPA
- Labeler DUNS
- 338430324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-30
- Public Version
- 1
- Public Version Date
- 2025-11-07
- Public Version Status
- New
- Public Device Record Key
- 7bb85d6a-36a4-464e-8626-164f7875c0ef
Device Description
THD Doppler Prbe is intended to be used with THD Revolution device for the treatment of haemorrhoidal disease, using the Transanal Haemorrhoidal Dearterialization technique. THD Doppler Probe in intended to be coupled with the THD Slide proctoscope and has been designed to obtain the maximum sensitivity to identify blood vessels. Its small size allows the physician an easy handling when used with the THD Slide proctoscope, which has a port to lodge the THD Doppler Probe body, leaving the operating field unobstructed. THD Doppler Probe (1s/ST) is individually packed and EO sterilized.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | Radiology | 892.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62211 | Invasive/noninvasive vascular ultrasound probe | A hand-operated component of a vascular ultrasound system intended to be used to measure the flow of blood both invasively by being applied to the outside of an isolated blood vessel perioperatively, and noninvasively by measuring flow in underlying vasculature from the body surface pre-/post-operatively, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18033737710354 | GS1 |
Customer Contacts
- Phone
- +390522634311
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090009 | 000 |