FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04035873066538
·
Model: 8300053475
·
Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 04035873066538
- Version / Model
- 8300053475
- Catalog Number
- 8300053475
- Company Name
- Henke-Sass, Wolf GmbH
- Labeler DUNS
- 317326411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-12
- Public Version
- 2
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 76fa56aa-77a3-4ddb-8e3f-3fbf4452519f
Device Description
Sinuscope, 2.7mm, 0°, 195, Autoclavable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35205 | Rigid optical nasopharyngoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035873066538 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.7 | Millimeter |