FDA UDI
In Commercial Distribution
🇺🇸 United States
Titanium-Vocal-Fold-Medial-Implant
DI: EHKM50010011
·
Model: 5001001
·
Heinz Kurz GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Titanium-Vocal-Fold-Medial-Implant
- Primary DI
- EHKM50010011
- Version / Model
- 5001001
- Catalog Number
- 5001001
- Company Name
- Heinz Kurz GmbH
- Labeler DUNS
- 341155720
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6f55a23d-fc84-448d-b4da-3d396e2e73e9
Device Description
Preformed vocal cord medialization implant
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46942 | Preformed vocal cord medialization implant | A solid, implantable device used for vocal cord medialization thyroplasty (removal of a "window" of cartilage from the outside of the voice box and replacing it with a prosthesis to push a paralyzed vocal cord toward the middle of the voice box) to treat patients with unilateral vocal cord paralysis to improve voice quality. It is available in a variety of shapes, materials [e.g., titanium (Ti), silicon, hydroxyapatite - also know as hydroxylapatite (HA)], and sizes (e.g., male and female). It can be adjusted intraoperatively to exactly fit the anatomic specifications of the patient, and may or may not be held in place with sutures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EHKM50010011 | HIBCC |
Customer Contacts
- Phone
- +49707291790
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991324 | 000 |