FDA UDI
In Commercial Distribution
🇺🇸 United States
TuohySono
DI: 14048223024482
·
Model: 1085-4K150
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- TuohySono
- Primary DI
- 14048223024482
- Version / Model
- 1085-4K150
- Catalog Number
- 1085-4K150
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 3
- Public Version Date
- 2021-03-17
- Public Version Status
- Update
- Public Device Record Key
- 016dd126-6256-4dd1-9bea-d354528a335d
- Distribution End Date
- 2025-03-15
Device Description
TuohySono 18G x 150mm with Cornerstone Reflectors
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58293 | Epidural needle, non-threaded | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14048223024482 | GS1 | ||||
| Unit of Use | 04048223024485 | GS1 |
Customer Contacts
- Phone
- +1(888)972-5865
- [email protected]