| Primary Device ID | 00817470012248 |
| NIH Device Record Key | de9a71af-23d6-4607-a868-9721c19f06fb |
| Commercial Distribution Discontinuation | 2018-08-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SPEEDHIP |
| Version Model Number | 23-2013 |
| Catalog Number | 23-2013 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817470012248 [Primary] |
| HXB | PROBE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817470012248]
Moist Heat or Steam Sterilization
[00817470012248]
Moist Heat or Steam Sterilization
[00817470012248]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-09-03 |
| Device Publish Date | 2018-05-21 |
| 00817470012255 | INLINE REUSABLE DRILL GUIDE SPEEDHIP |
| 00817470012248 | INLINE REUSABLE OBTURATOR SPEEDHIP |
| 00885556724590 | INLINE REUSABLE DRILL GUIDE SPEEDHIP |
| 00885556724583 | INLINE REUSABLE OBTURATOR SPEEDHIP |
| 00885556724576 | INLINE REUSABLE DRILL SPEEDHIP |