Duns Number:338430324
Device Description: THD Slide is specifically designed to be immediately used with the THD Evolution/Revolutio THD Slide is specifically designed to be immediately used with the THD Evolution/Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD Slide One box contains 10 individually packed disposable doppler probes, which can be immediately be used without preventive cleaning and sterilisation. The box also con-tains 10 absorbable sutures packs (6 sutures each pack) and 10 THD Spon-Anal haemostatic sponges
Catalog Number
800070
Brand Name
THD Revolution
Version/Model Number
THD Slide One USA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090009,K090009,K090009,K090009
Product Code
JAF
Product Code Name
Monitor, Ultrasonic, Nonfetal
Public Device Record Key
c0badd07-fc58-402a-9ce7-3dd35ce31bd8
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 30, 2016
Package DI Number
38033737710730
Quantity per Package
2
Contains DI Package
28033737710733
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 53 |