FDA UDI
In Commercial Distribution
🇺🇸 United States
EVONOS
DI: 00821925016033
·
Model: 130882
·
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
- 00821925016033
- Version / Model
- 130882
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-10
- Public Version
- 4
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- dfcba2f2-02e7-4514-ab69-5af288f2a024
Device Description
HEXAGONAL BLADE HANDLE # 3H 3.9" (10 CM) LONG
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 |
|---|---|---|---|---|
| 32261 | General/plastic surgery mirror | A reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925016033 | GS1 |