FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00858965006182
·
Model: TDL109
·
PAJUNK MEDICAL SYSTEMS, LP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00858965006182
- Version / Model
- TDL109
- 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
- 2018-08-30
- Public Version
- 3
- Public Version Date
- 2023-12-07
- Public Version Status
- Update
- Public Device Record Key
- 3da7510e-2a8f-4831-b814-1d126638292f
Device Description
Support Tray (SINGLE SHOT NERVE BLOCK SUPPORT TRAY)
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 |
|---|---|---|---|---|
| 64346 | Peripheral anaesthesia single-administration set, medicated | A collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858965006182 | GS1 | ||||
| Package | 20858965006186 | GS1 | NA | 10 | In Commercial Distribution | |
| Package | 50858965006187 | GS1 | NA | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 770-493-6832
- [email protected]