FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00840682118026
·
Model: SP6-12
·
GE Healthcare Austria GmbH & Co OG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00840682118026
- Version / Model
- SP6-12
- Company Name
- GE Healthcare Austria GmbH & Co OG
- Labeler DUNS
- 300599979
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-15
- Public Version
- 5
- Public Version Date
- 2020-05-11
- Public Version Status
- Update
- Public Device Record Key
- d262ce87-fcd0-4244-8eeb-f5078a4aff87
- Distribution End Date
- 2019-12-09
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IYN | System, imaging, pulsed doppler, ultrasonic | Radiology | 892.1550 | 2 |
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40768 | Extracorporeal ultrasound imaging transducer, hand-held | A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682118026 | GS1 |
Customer Contacts
- Phone
- +1(800)437-1171
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041688 | 000 |