| Primary Device ID | M695RAHT010000 |
| NIH Device Record Key | bc99af40-a447-40e2-b7b3-c87e922a0cfc |
| Commercial Distribution Discontinuation | 2024-07-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | STERIFLEX HT |
| Version Model Number | RAHT-01000 |
| Catalog Number | RAHT-01000 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical LLC |
| 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 | 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 |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M695RAHT010000 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-07-26 |
| Device Publish Date | 2019-12-19 |
| M695RAHT2X15S100 | STERIFLEX HT Ø2.0mm x 15mm - 10 |
| M695RAHT2X15C0 | STERIFLEX HT Ø2.0mm x 15mm |
| M695RAHT2X13S100 | STERIFLEX HT Ø2.0mm x 13mm - 10 |
| M695RAHT2X13C0 | STERIFLEX HT Ø2.0mm x 13mm |
| M695RAHT25X15S100 | STERIFLEX HT Ø2.5mm x 15mm - 10 |
| M695RAHT25X15C0 | STERIFLEX HT Ø2.5mm x 15mm |
| M695RAHT3X15C0 | STERIFLEX HT Ø3.0mm x 15mm |
| M695RAHT010110 | Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6") Kit |
| M695RAHT010090 | Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6") Kit |
| M695RAHT010000 | Mini Fixed AO Handle |