FDA UDI
In Commercial Distribution
🇺🇸 United States
Rectoscope equipment
DI: 08033638801536
·
Model: Rectoscope equipment with LED and insufflator
·
SAPI MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rectoscope equipment
- Primary DI
- 08033638801536
- Version / Model
- Rectoscope equipment with LED and insufflator
- Catalog Number
- A.4520LINS
- Company Name
- SAPI MED SPA
- Labeler DUNS
- 437320088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-17
- Public Version
- 1
- Public Version Date
- 2025-02-25
- Public Version Status
- New
- Public Device Record Key
- afdb3b8b-2a9a-4054-a90b-2734800e3f4e
Device Description
Non-sterile and disposable rectoscope equipment of 12,5mm diameter with insufflator and built-in LED light.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDM | Sigmoidoscope, Rigid, Non-Electrical | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40502 | Optical proctoscope, single-use | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033638801536 | GS1 | ||||
| Package | 08033638801604 | GS1 | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070915 | 000 |