FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00858965006816
·
Model: TDLU233
·
PAJUNK MEDICAL SYSTEMS, LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00858965006816
- Version / Model
- TDLU233
- 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
- 2023-09-01
- Public Version
- 1
- Public Version Date
- 2023-09-11
- Public Version Status
- New
- Public Device Record Key
- b7fec193-8662-4f47-8a3b-746e03d77e19
Device Description
Continuous Nerve Block Support Tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| 66346 | Local/regional anaesthesia support kit | A collection of noninvasive devices intended to support a local and/or regional anaesthesia procedure (e.g., spinal/epidural anaesthesia, peripheral nerve block). It includes supportive devices such as drapes, bowls, towels, and dressing forceps; neither a needle, anaesthesia catheter, nor medication is included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50858965006811 | GS1 | NA | 25 | In Commercial Distribution | |
| Primary | 00858965006816 | GS1 |
Customer Contacts
- Phone
- 770-493-6832
- [email protected]