FDA UDI
In Commercial Distribution
🇺🇸 United States
Pack of 1000 pcs. disposable ear specula Ø 3 mm,
DI: 04045396147515
·
Model: 10803-533
·
Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pack of 1000 pcs. disposable ear specula Ø 3 mm,
- Primary DI
- 04045396147515
- Version / Model
- 10803-533
- Catalog Number
- 10803-533
- 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
- a1c5f4da-aef2-44ab-a142-66655eabd9fa
Device Description
With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illuminated and examined.
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 |
|---|---|---|---|---|
| EPY | Speculum, Ent | General, Plastic Surgery | 878.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33395 | Ear speculum, reusable | A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396147515 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932506 | 000 |