| Primary Device ID | B2086683153 |
| NIH Device Record Key | 24d02f97-dd60-4cb2-8198-0ac56ed8f459 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easy Glide Pen Needle 31G X 5/16" (8mm) |
| Version Model Number | 668315 |
| Company DUNS | 796779283 |
| Company Name | GLOBAL DIABETIC DISTRIBUTORS 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 | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B2086683150 [Primary] |
| HIBCC | B2086683151 [Package] Contains: B2086683150 Package: Box [100 Units] In Commercial Distribution |
| HIBCC | B2086683152 [Package] Contains: B2086683151 Package: Inner Case [6 Units] In Commercial Distribution |
| HIBCC | B2086683153 [Package] Contains: B2086683152 Package: Shipping Case [8 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-16 |
| B2086720203 - Easy Glide 20cc Luer Lock Syringe | 2019-09-30 Easy Glide 20cc Luer Lock Syringe |
| B2086733303 - Easy Glide 30cc Luer Lock Syringe | 2019-05-07 Easy Glide 30cc Luer Lock Syringe |
| B2086730303 - Easy Glide 3cc Luer Lock Syringe | 2019-04-17 Easy Glide 3cc Luer Lock Syringe |
| B2086710203 - Easy Glide 10cc Luer Lock Syringe | 2018-09-12 Easy Glide 10cc Luer Lock Syringe |
| B2086713503 - Easy Glide 1cc Luer Lock Syringe | 2018-09-12 Easy Glide 1cc Luer Lock Syringe |
| B2086760603 - Easy Glide 60cc Cath Tip Syringe | 2018-09-12 Easy Glide 60cc Cath Tip Syringe |
| B2086766600 - Easy Glide 60cc Luer Lock Syringe | 2018-09-12 Easy Glide 60cc Luer Lock Syringe |
| B2086295013 - Easy Glide INSULIN SYRINGE 1 ML 29GX1/2" | 2018-07-06 Easy Glide INSULIN SYRINGE 1 ML 29GX1/2" |