FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-CARE™ Safety Syringe Allergy Tray
DI: 10818392015352
·
Model: 100035IM
·
Sol-Millennium Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
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Basic Information
- Brand Name
- SOL-CARE™ Safety Syringe Allergy Tray
- Primary DI
- 10818392015352
- Version / Model
- 100035IM
- Company Name
- Sol-Millennium Medical, Inc.
- Labeler DUNS
- 069590113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2025-05-01
- Public Version Status
- Update
- Public Device Record Key
- fa571248-f561-43a6-a477-19975e76a9c4
Device Description
A sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. In addition, the device is also designed to aid in the prevention of needle stick injuries. .5ml 26g x 3/8" IDB
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| MEG | SYRINGE, ANTISTICK | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45042 | Metered-delivery hypodermic syringe/needle | A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20818392015359 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 10818392015352 | GS1 | ||||
| Unit of Use | 00818392015355 | GS1 |
Customer Contacts
- Phone
- 833-637-0857
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.5 | Milliliter | |
| Length | 10 | Millimeter | |
| Needle Gauge | 26 | Gauge |