FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00858965006151
·
Model: TDL106
·
PAJUNK MEDICAL SYSTEMS, LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00858965006151
- Version / Model
- TDL106
- Catalog Number
- NA
- Company Name
- PAJUNK MEDICAL SYSTEMS, LP
- Labeler DUNS
- 136718553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-04
- Public Version
- 3
- Public Version Date
- 2023-12-25
- Public Version Status
- Update
- Public Device Record Key
- accbdd53-f053-4cf5-bd38-23a20805cba2
Device Description
SonoLong Echo Tray 18G x 2'' (50mm) echogenic needle with Tuohy tip, 60cm injection tubing, 60cm stimulation cable, SonoLong Echo 20G x 20'' (50cm) echogenic catheter with closed tip and 3 lateral openings, catheter container with introducer aid, 30cm graduation, clamping adapter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| OGJ | Nerve Block Tray | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64347 | Peripheral anaesthesia catheter set, medicated | A collection of devices intended for the continuous-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent, an anaesthesia catheter, and an anaesthesia needle usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20858965006155 | GS1 | NA | 10 | In Commercial Distribution | |
| Primary | 00858965006151 | GS1 |
Customer Contacts
- Phone
- 770-493-6832
- [email protected]