FDA UDI
In Commercial Distribution
🇺🇸 United States
Gyrus ACMI
DI: 00821925038349
·
Model: E-1F
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Gyrus ACMI
- Primary DI
- 00821925038349
- Version / Model
- E-1F
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 4
- Public Version Date
- 2023-08-10
- Public Version Status
- Update
- Public Device Record Key
- 8ff8c588-2583-43c2-ba9a-0dc596709c1a
Device Description
Electrohydraulic Lithotripsy Probe 1.9 FR (0.633 mm) X 120 CM
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FFK | Lithotriptor, electro-hydraulic | Gastroenterology, Urology | 876.4480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61846 | Ultrasonic surgical system transducer | A hand-held component of an ultrasonic surgical system intended to be connected to a system holder/tip or combined holder/tip, whereby it is designed to convert high frequency electrical current from a generator into an ultrasonic oscillation, to fragment hard and/or soft tissue cells for cutting and/or coagulating tissue during surgery (e.g., arthroscopic); it is not dedicated to dental applications. It may be referred to as a handpiece however it does not include controls and cannot be directly connected to the tip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00821925002043 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00821925038349 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980492 | 000 |