FDA UDI
In Commercial Distribution
🇺🇸 United States
Laryngoskop FS2
DI: B809M105220300700
·
Model: 1
·
orlvision GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Laryngoskop FS2
- Primary DI
- B809M105220300700
- Version / Model
- 1
- Company Name
- orlvision GmbH
- Labeler DUNS
- 341467978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-19
- Public Version
- 1
- Public Version Date
- 2020-10-27
- Public Version Status
- New
- Public Device Record Key
- 9e034905-89b0-4974-b931-5d834f662cca
Device Description
This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45043 | Flexible video nasopharyngoscope | An endoscope with a flexible 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 by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B809M105220300700 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150248 | 000 |