FDA UDI
In Commercial Distribution
🇺🇸 United States
FEATHERVAC DISPOSABLE STAPES SEAT
DI: 00844505007122
·
Model: 906-002
·
Grace Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FEATHERVAC DISPOSABLE STAPES SEAT
- Primary DI
- 00844505007122
- Version / Model
- 906-002
- Company Name
- Grace Medical, Inc.
- Labeler DUNS
- 030849173
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-21
- Public Version
- 2
- Public Version Date
- 2021-01-18
- Public Version Status
- Update
- Public Device Record Key
- f32e6847-d5e4-499a-b78f-81bf70e36bf6
Device Description
FEATHERVAC DISPOSABLE STAPES SEAT
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60396 | Ossicular prosthesis introducer tip | A sterile surgical instrument intended to be fitted to an ossicular prosthesis introducer handpiece for suction-lifting/manipulation of an ossicular prosthesis during implantation. It typically consists of a piece of metal tubing with a distal end designed to house a specific ossicular prosthesis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844505007122 | GS1 | ||||
| Package | 10844505007129 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(866)472-2363
- [email protected]