| Primary Device ID | 10850002860723 |
| NIH Device Record Key | 321123bb-8115-462d-abc3-ba74a1b98979 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort EZ Pro |
| Version Model Number | SPN-31G4 |
| Catalog Number | 50002-0860-72 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 4 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002860726 [Primary] |
| GS1 | 10850002860723 [Package] Contains: 00850002860726 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 20850002860720 [Unit of Use] |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-09 |
| Device Publish Date | 2023-08-01 |
| 10850002860723 | Safety Insulin Pen Needles - 31G 4mm 100 count |
| 10850002860716 | Safety Insulin Pen Needles - 31G 5mm 100 count |
| 10850002860709 | Safety Insulin Pen Needles - 30G 8mm 100 count |