FDA UDI
In Commercial Distribution
🇺🇸 United States
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
DI: 08033737710487
·
Model: THD Light - Scope LED Truncated Anoscope Not Sterile
·
THD SPA
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
- Primary DI
- 08033737710487
- Version / Model
- THD Light - Scope LED Truncated Anoscope Not Sterile
- Catalog Number
- 800092
- Company Name
- THD SPA
- Labeler DUNS
- 338430324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 5
- Public Version Date
- 2024-10-28
- Public Version Status
- Update
- Public Device Record Key
- 2d5bd3b9-cee0-4222-b96f-869c81a58f7c
Device Description
The Light-Score LED anoscope is a disposable medical device deemed for investigation of the anal canal. The Light-Score LED anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The Light-Score LED anoscope is ready-to-use and does not need for other tools.
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FER | Anoscope And Accessories | Gastroenterology, Urology | 876.1500 | 2 |
| GCP | Endoscope, Ac-Powered And Accessories | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44914 | Optical anoscope, single-use | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033737710487 | GS1 | ||||
| Package | 28033737710481 | GS1 | 50 | In Commercial Distribution | ||
| Package | 18033737710484 | GS1 | 10 | In Commercial Distribution | ||
| Package | 38033737710488 | GS1 | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +390522634311
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 22.1 | Millimeter | |
| Length | 90 | Millimeter |