FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MICRO-MATE®
DI: 00816329020199
·
Model: 5019
·
CADENCE SCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICRO-MATE®
- Primary DI
- 00816329020199
- Version / Model
- 5019
- Catalog Number
- 5019
- Company Name
- CADENCE SCIENCE, INC.
- Labeler DUNS
- 001618818
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2020-02-27
- Public Version Status
- Update
- Public Device Record Key
- 35ae99b3-b50a-485d-9d30-0270fe0f06ae
- Distribution End Date
- 2019-11-30
Device Description
Interchangeable 5mL in 1/5mL, Glass Tip
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62182 | General-purpose syringe, reusable | A non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); it is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment of the female connector (hub) of a hypodermic needle or an administration set. It is typically made of glass and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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 | 00816329020199 | GS1 | ||||
| Package | 00816329020168 | GS1 | Box | 12 | Not in Commercial Distribution | 2019-11-30 |
Customer Contacts
- Phone
- 18002523371
- [email protected]