FDA UDI
In Commercial Distribution
🇺🇸 United States
Eliachar Laryngeal Stent
DI: 00815347023328
·
Model: ELL-3000
·
HOOD, E BENSON LABORATORIES INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eliachar Laryngeal Stent
- Primary DI
- 00815347023328
- Version / Model
- ELL-3000
- Company Name
- HOOD, E BENSON LABORATORIES INC
- Labeler DUNS
- 076603380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-22
- Public Version
- 4
- Public Version Date
- 2020-06-05
- Public Version Status
- Update
- Public Device Record Key
- 35d5ceeb-a627-416a-b745-3b97d91c9ed4
Device Description
Eliachar Laryngeal Stent
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWN | Prosthesis, Larynx (Stents And Keels) | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35404 | Tracheostomy tube, non-reinforced, non-customized, single-use | A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815347023328 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K884810 | 000 |