FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TUOHY SONO
DI: 04048223115404
·
Model: 1085-4E120
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- TUOHY SONO
- Primary DI
- 04048223115404
- Version / Model
- 1085-4E120
- Catalog Number
- 1085-4E120
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-07-07
- Public Version
- 5
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- 0dd0813f-1f15-4999-880e-8cf89d90712a
- Distribution End Date
- 2025-01-17
Device Description
Tuohy-Kanüle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04048223112595 | GS1 | ||||
| Previous | 04048223054321 | GS1 | ||||
| Primary | 04048223115404 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113207 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 120.0 | Millimeter | |
| Outer Diameter | 0.7 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 65 Percent (%) Relative Humidity