SOL-CARE™ Insulin Syringe w/Fixed Needle
GUDID 10818392013921
SOL-CARE 1ml Insulin Syringe w/Fixed Needle 31G*5/16 (U-100 Insulin Only)
SOL-MILLENNIUM MEDICAL INC
Insulin syringe/needle, safety| Primary Device ID | 10818392013921 |
| NIH Device Record Key | 39c4e8f9-1cb5-4ee6-a1d2-d30e5190d70b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOL-CARE™ Insulin Syringe w/Fixed Needle |
| Version Model Number | 100091IM |
| 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 | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com |
Device Dimensions
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Total Volume | 1 Milliliter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818392013924 [Primary] |
| GS1 | 10818392013921 [Package] Contains: 00818392013924 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 20818392013928 [Package] 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 | 2017-10-23 |
Devices Manufactured by SOL-MILLENNIUM MEDICAL INC
| 00840368517099 - TYPENEX | 2024-05-20 INTRODUCER SET |
| 00840368516542 - TYPENEX | 2024-04-23 INTRODUCER SET |
| 00840368514326 - TYPENEX | 2024-01-12 INTRODUCER SET |
| 00840368514364 - TYPENEX | 2024-01-12 INTRODUCER SET |
| 20818392014666 - SOL-CARE Safety Multi-Sample Needle | 2019-10-24 SOL-CARE Safety Multi-Sample Needle 21G*1 1/4 |
| 20818392014680 - SOL-CARE Safety Multi-Sample Needle | 2019-10-24 SOL-CARE Safety Multi-Sample Needle 22G*1 1/4 |
| 20818392014956 - SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder | 2019-10-24 SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 21G*1 1/4 |
| 20818392014970 - SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder | 2019-10-24 SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 22G*1 1/4 |
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 |
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