FDA UDI
In Commercial Distribution
🇺🇸 United States
Self-light anoscopes
DI: 08033638802885
·
Model: Diagnostic Self-Led-Light
·
SAPI MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Self-light anoscopes
- Primary DI
- 08033638802885
- Version / Model
- Diagnostic Self-Led-Light
- Catalog Number
- A.4019L
- Company Name
- SAPI MED SPA
- Labeler DUNS
- 437320088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-27
- Public Version
- 2
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 6daf9866-54b2-4540-aef6-570c3e6c1524
Device Description
SELF-LED-LIGHT - Diagnostic/paediatric trunk-end proctoscope with built-in LED light. Disposable. Tube length 54mm. Tube diameter 18mm.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- 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 |
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 |
|---|---|---|---|---|---|---|
| Package | 08033638802892 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 08033638802885 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070913 | 000 |