FDA UDI
In Commercial Distribution
🇺🇸 United States
SonoTAP II NRFit
DI: 04048223077962
·
Model: 1265-3Y050
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SonoTAP II NRFit
- Primary DI
- 04048223077962
- Version / Model
- 1265-3Y050
- Catalog Number
- 1265-3Y050
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-27
- Public Version
- 1
- Public Version Date
- 2025-07-07
- Public Version Status
- New
- Public Device Record Key
- 7f2afc4a-b935-4692-b33f-4cb6558f21a1
Device Description
SonoTAP II NRFit 24G x 50mm with bevel tip and Cornerstone Reflectors
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
- 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 |
|---|---|---|---|---|
| 61548 | Rapid-contact laboratory freezer | A mains electricity (AC-powered) appliance intended to be used to rapidly freeze bags containing plasma or other biological specimens to a core temperature of -30° Celsius (-22° Fahrenheit). It typically consists of a single or multiple shelves with adjustable contact plates, between which the bags are placed for freezing. It is not intended for storage; frozen bags are subsequently transferred to an appropriate storage freezer. It has sensors, controls, and monitors to display freezing progress (time/temperature graphs). It may include associated software for documentation of data and tracing of the bags. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04048223057384 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04048223077962 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243525 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 24.0 | Gauge | |
| Length | 50.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity