THD PressProbe
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Basic Information
- Brand Name
- THD PressProbe
- Primary DI
- 08033737711286
- Version / Model
- THD PressProbe (Env)
- Catalog Number
- 800144
- Company Name
- THD SPA
- Labeler DUNS
- 338430324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-20
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 476b6e7d-5867-480b-b3d9-3d8ce67f5f67
Device Description
THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination. Each pack contains a proprietary Probe Card, to enable the recording of the examination.
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLA | Monitor, Esophageal Motility, And Tube | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17745 | Gastrointestinal motility manometric catheter, non-electronic | A non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28033737711372 | GS1 | Cartoon Box | 2 | In Commercial Distribution | |
| Package | 28033737711280 | GS1 | Cartoon Box | 50 | In Commercial Distribution | |
| Primary | 08033737711286 | GS1 | ||||
| Package | 28033737711341 | GS1 | Cartoon Box | 1 | In Commercial Distribution | |
| Package | 18033737711283 | GS1 | Cartoon Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +390522634311
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161785 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 165 | Millimeter | |
| Outer Diameter | 16 | Millimeter | |
| Weight | 25 | Gram |