FDA UDI
In Commercial Distribution
🇺🇸 United States
EVONOS
DI: 00821925011809
·
Model: 130105
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EVONOS
- Primary DI
- 00821925011809
- Version / Model
- 130105
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-07
- Public Version
- 5
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- e7480e82-548a-4ef3-9304-d1f66e754783
Device Description
HOUGH SPATULA 1.52 MM TIP WIDTH STAINLESS STEEL EBONY FINISH
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 |
|---|---|---|---|---|
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35346 | Middle ear spatula | A hand-held manual surgical instrument designed to manipulate middle ear tissue or structures during ear/nose/throat (ENT) surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a flat blunt blade (no sharp edges) at the distal tip. Progressing from the handle to the distal tip the shaft or the blade may be straight, curved, or turn at various angles. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925011809 | GS1 |