FDA UDI
In Commercial Distribution
🇺🇸 United States
ri-scope® F.O. nasal speculum LED 3.5 V,
DI: 04045396147157
·
Model: 10575-301
·
Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ri-scope® F.O. nasal speculum LED 3.5 V,
- Primary DI
- 04045396147157
- Version / Model
- 10575-301
- Catalog Number
- 10575-301
- Company Name
- Rudolf Riester GmbH
- Labeler DUNS
- 537208717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-28
- Public Version
- 1
- Public Version Date
- 2021-02-05
- Public Version Status
- New
- Public Device Record Key
- a501b743-6b02-4d5c-8c31-9320b354349a
Device Description
The nasal speculum is produced for illumination and therefore examination of the inside of the nose.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45085 | ENT diagnostic set | A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396147157 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950913 | 000 |