FDA UDI
In Commercial Distribution
🇺🇸 United States
Gyrus ACMI
DI: 00821925004801
·
Model: 253F8
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gyrus ACMI
- Primary DI
- 00821925004801
- Version / Model
- 253F8
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-23
- Public Version
- 2
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 5b47eb2d-85e3-48a3-a2e9-aeb60001effa
Device Description
Fulgurating Electrode, Domed Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60261 | Foetal/maternal multiple physiological parameter electronic-signal simulator | A hand-held, battery-powered device intended to imitate a variety of physiological parameters and a variety of conditions (both foetal and maternal) expressed during pregnancy (e.g., TOCO, uterine and foetal heart activity) in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. It typically consists of a small electronic box with a digital display, controls, and a number of electronic outputs; it may be used in conjunction with a foetal heart simulator (for foetal heart simulation). This device is intended to be used by a healthcare provider in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925004801 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K890328 | 000 |