FDA UDI
In Commercial Distribution
🇺🇸 United States
MSI Precision Specialty Instruments
DI: 00194613091712
·
Model: 38-9194BX
·
Med Saver, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MSI Precision Specialty Instruments
- Primary DI
- 00194613091712
- Version / Model
- 38-9194BX
- Company Name
- Med Saver, Inc.
- Labeler DUNS
- 556623486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 2
- Public Version Date
- 2025-07-30
- Public Version Status
- Update
- Public Device Record Key
- 4571260b-783c-4ba9-a68f-b02aa56f1039
Device Description
Heparin Needle, 13ga, Luer Lock, Overall Length 3" (76mm)
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 |
|---|---|---|---|---|
| 62317 | Vascular irrigation cannula, coronary artery, reusable | A rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is typically achieved with the use of a removable stylet or trocar blade. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194613091712 | GS1 |
Customer Contacts
- Phone
- +1(610)935-8181
- [email protected]