FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED INCORPORATED
DI: 00198506060410
·
Model: 42-1307
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELMED INCORPORATED
- Primary DI
- 00198506060410
- Version / Model
- 42-1307
- Catalog Number
- 42-1307
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 1
- Public Version Date
- 2024-09-03
- Public Version Status
- New
- Public Device Record Key
- c53ee27b-fd20-4c98-a8d3-213ba7f37376
Device Description
Handle for Laryngoscope for LEWY Chest support and Operating Laryngoscope
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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43946 | Rigid optical laryngopharyngoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198506060410 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]