FDA UDI
In Commercial Distribution
🇺🇸 United States
CLASSIC STAPES PROSTHESIS LARGE WELL 1 MM ID NARROW SHAFT 04 MM 5 MM LONG TITANI
DI: 00821925028616
·
Model: 70142150
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CLASSIC STAPES PROSTHESIS LARGE WELL 1 MM ID NARROW SHAFT 04 MM 5 MM LONG TITANI
- Primary DI
- 00821925028616
- Version / Model
- 70142150
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 556eb7c2-f1cf-4c4a-ab80-0b4ab2fd348f
Device Description
Replace the portion of the ossicular chain that has lost its function due to disease congenital defect or other pathological process.
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 |
|---|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | Ear, Nose, Throat | 874.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33310 | Polyethylene craniofacial tissue reconstructive material | A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925028616 | GS1 |
Customer Contacts
- Phone
- 18002623540
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K802873 | 000 |