FDA UDI
In Commercial Distribution
🇺🇸 United States
miniARM® multiSTATION™ System
DI: 00850200006599
·
Model: 080415
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- miniARM® multiSTATION™ System
- Primary DI
- 00850200006599
- Version / Model
- 080415
- Catalog Number
- 080415
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-13
- Public Version
- 3
- Public Version Date
- 2022-11-10
- Public Version Status
- Update
- Public Device Record Key
- 9d4112cc-cf57-4613-923e-efa44c5b9017
Device Description
miniARM® CANNULA ADAPTOR KIT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEA | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62857 | Pleuroscopic/mediastinoscopic access cannula, reusable | A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest to provide access to the pleural and/or mediastinal cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive procedure; it is not intended for pericardial access. It provides an entry between adjacent ribs and once in place is intended to remain in position for the duration of the procedure. It may include a trocar with a sharp or blunt tip intended to assist introduction; devices with the trocar included it may be referred to as a trocar or trocar assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850200006599 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]