| Primary Device ID | 20850083784328 |
| NIH Device Record Key | f1cf79a0-ebff-4b24-a9ab-0b605aa8a473 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort EZ |
| Version Model Number | SSTB25G1ML58 |
| Company DUNS | 116722847 |
| Company Name | S.D.I. USA, INC. |
| Device Count | 100 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Needle Gauge | 25 Gauge |
| Length | 0.625 Inch |
| Total Volume | 1 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850083784324 [Primary] |
| GS1 | 20850083784328 [Unit of Use] |
| MEG | Syringe, Antistick |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-23 |
| Device Publish Date | 2026-02-13 |
| 00850002860214 | Insulin Syringe - 100 count |
| 00850002860207 | Insulin Syringe - 100 count |
| 00850002860191 | Insulin Syringe - 100 count |
| 00850002860184 | Insulin Syringe - 100 count |
| 00850002860177 | Insulin Syringe - 100 count |
| 00850002860160 | Insulin Syringe - 100 count |
| 00850002860153 | Insulin Syringe - 100 count |
| 00850002860146 | Insulin Syringe - 100 count |
| 00850002860139 | Insulin Syringe - 100 count |
| 00850002860122 | Insulin Syringe - 100 count |
| 00850002860115 | Insulin Pen Needle |
| 00850002860108 | Insulin Pen Needle |
| 00850002860092 | Insulin Pen Needle |
| 00850002860085 | Insulin Pen Needle |
| 00850002860078 | Insulin Pen Needle |
| 00850002860061 | Insulin Pen Needle |
| 00850002860054 | Insulin Pen Needle |
| 00850002860047 | Insulin Pen Needle |
| 00850002860030 | Insulin Pen Needle |
| 00850002860023 | Insulin Pen Needle |
| 20850083784403 | Blunt Fill Needle 18 Gauge 1.5" 100Ea/Bx 10bx/cs |
| 20850083784342 | 18G 1.5" 3mL syringe (Exchangeable Needle) Non-Safety Needle Ultra Thin Wall 100/bx 8bx/cs |
| 20850083784328 | Safety Tuberculin 25G 5/8 in. 1 mL Syringe Hinged Safety Needle Ultra Thin Wall (Exchangeable Ne |
| 20850083784274 | Safety 23G 1 in. 3mL Syringe (Exchangeable Needle) Hinged Safety Needle Ultra Thin Wall 100/bx 8 |
| 20850083784175 | Safety Hypodermic Needle 25G x 1" Ultra Thin Wall 100/bx 8bx/ ctn |
| 20850083784052 | Hypodermic Needle 18G x 1" Thin Wall 100/bx 10bx/ctn |
| 20850083784045 | Luer Lock Syringe 1ML (Insulin Graduations) 100/box 10bx/ctn |
| 20850083784007 | Luer Lock 1ML 100/box 8bx/ctn Graduations 0.01 mL Increments |