| Primary Device ID | 10383790000281 |
| NIH Device Record Key | 56f21143-b4fc-4530-98a8-3b992802ff40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE |
| Version Model Number | 17GX1-1/4 |
| Catalog Number | FS+173230BC-G |
| Company DUNS | 797372554 |
| Company Name | NIPRO MEDICAL CORPORATION |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790000284 [Primary] |
| GS1 | 10383790000281 [Package] Contains: 00383790000284 Package: Carton [50 Units] In Commercial Distribution |
| GS1 | 40383790000282 [Package] Package: Case [10 Units] In Commercial Distribution |
| FIE | Needle, fistula |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-12-20 |
| Device Publish Date | 2016-04-01 |
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