SOL-CARE™ Insulin Safety Syringe with Fixed Needle
GUDID 20818392014802
Used to inject insulin into the body. In addition, the device is designed to aid in the prevention of needle stick injuries.
SOL-MILLENNIUM MEDICAL INC
Insulin syringe/needle, safety| Primary Device ID | 20818392014802 |
| NIH Device Record Key | 595f17b2-c7b5-47ff-9032-e7214a1478f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOL-CARE™ Insulin Safety Syringe with Fixed Needle |
| Version Model Number | 100002IM |
| Company DUNS | 069590113 |
| Company Name | SOL-MILLENNIUM MEDICAL INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com | |
| Phone | 8336370857 |
| info@solm.com |
Device Dimensions
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 29 Gauge |
| Length | 12.5 Millimeter |
| Total Volume | 0.5 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818392014808 [Primary] |
| GS1 | 10818392014805 [Package] Contains: 00818392014808 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 20818392014802 [Package] Contains: 10818392014805 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092413
FDA Product Code
| MEG | SYRINGE, ANTISTICK |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [SOL-CARE™ Insulin Safety Syringe with Fixed Needle]
| 10818392015895 | Used to inject insulin into the body. In addition, the device is designed to aid in the preventi |
| 10818392015888 | Used to inject insulin into the body. In addition, the device is designed to aid in the preventi |
| 10818392015710 | Used to inject insulin into the body. In addition, the device is designed to aid in the preventi |
| 20818392014901 | Used to inject insulin into the body. In addition, the device is designed to aid in the preventi |
| 20818392014802 | Used to inject insulin into the body. In addition, the device is designed to aid in the preventi |
| 20818392011078 | Used to inject insulin into the body. In addition, the device is designed to aid in the preventi |
Trademark Results [SOL-CARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOL-CARE 85467280 4580518 Live/Registered |
SOL-MILLENNIUM MEDICAL HK LIMITED 2011-11-08 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.