FDA UDI
In Commercial Distribution
🇺🇸 United States
miniARM® multiSTATION™ System
DI: 00850012846154
·
Model: 080900
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- miniARM® multiSTATION™ System
- Primary DI
- 00850012846154
- Version / Model
- 080900
- Catalog Number
- 080900
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-28
- Public Version
- 2
- Public Version Date
- 2022-11-10
- Public Version Status
- Update
- Public Device Record Key
- e12aaacb-3d5c-4910-b861-f33119da6446
Device Description
SubX™ STERNAL ASCENDER™ SYSTEM
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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64146 | Surgical instrument assist arm system structural component | A connecting component of a surgical instrument assist arm system intended to be integrated as part of the structural assembly of the arm. It is a structural component (not a repair tool) and may be in the form of an arm piece/rod, base unit, clamp, actuator, or instrument holding component; it is not intended to be used as the distal tissue interfacing instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012846154 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature.