FDA UDI
In Commercial Distribution
🇺🇸 United States
Gyrus ACMI
DI: 00821925008045
·
Model: UCA
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Gyrus ACMI
- Primary DI
- 00821925008045
- Version / Model
- UCA
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-24
- Public Version
- 2
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 15cf08f3-c9d4-480c-9d27-b67ddbd63561
Device Description
Universal Active Cord Adapter For Use With DAC/GDAC And ValleyLab Or Bovie Electrosurgical Units
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47577 | Medium-wave diathermy treatment system electrode, active | A hand-operated electrical conductor that is a component of a medium-wave diathermy treatment system and designed to be moved over the skin surface of a patient by an operator to deliver an electrical current at a pre-set frequency to develop heat in subcutaneous tissues. It is typically designed with permanently attached cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925008045 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914883 | 000 |