| Primary Device ID | B331586102045 |
| NIH Device Record Key | 0166e149-3e40-4d3c-92e4-ba9c8bb7e917 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signature |
| Version Model Number | 5861020-45 |
| Company DUNS | 362145604 |
| Company Name | SILEX MEDICAL, LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B331586102045 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B331586102045]
Moist Heat or Steam Sterilization
[B331586102045]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-14 |
| B3335851032 | Blunt Grasping Forceps |
| B331588109345 | Locking Long Hunter Style Bowel Grasping Forceps |
| B3315881093 | Locking Hunter Style Bowel Grasping Forceps |
| B331588109245 | Locking Long 40MM Debakey Grasping Forceps |
| B3315881092 | Locking 40MM Debakey Grasping Forceps |
| B331588108845 | Locking Long Single Modified Allis Grasping Forceps |
| B3315881088 | Locking Single Modified Allis Grasping Forceps |
| B331588108745 | Locking Long Double Modified Allis Grasping Forceps |
| B3315881087 | Locking Double Modified Allis Grasping Forceps |
| B3315881079 | Locking 10MM Babcock Grasping Forceps |
| B331588107245 | Locking Long Cup Grasping Forceps |
| B3315881072 | Locking Cup Grasping Forceps |
| B331588106945 | Locking Long Cobra Tooth Grasping Forceps |
| B3315881069 | Locking Cobra Tooth Grasping Forceps |
| B3315881068 | Locking 10MM Mixter Dissecting Forceps |
| B331588106745 | Locking Long Maryland Dissecting Forceps |
| B3315881067 | Locking Maryland Dissecting Forceps |
| B331588106645 | Locking Long Mixter Dissecting Forceps |
| B3315881066 | Locking Mixter Dissecting Forceps |
| B331588106345 | Locking Long Right Angle Dissecting Forceps |
| B3315881063 | Locking Right Angle Dissecting Forceps |
| B331588105645 | Locking Long Single Action Retraction Grasping Forceps |
| B3315881056 | Locking Single Action Retraction Grasping Forceps |
| B331588105345 | Locking Long Atraumatic Grasping Forceps |
| B3315881053 | Locking Atraumatic Grasping Forceps |
| B331588105145 | Locking Long Single Action Wave Grasping Forceps |
| B3315881051 | Locking Single Action Wave Grasping Forceps |
| B331588105045 | Locking Long Fundus Tri-Max Grasping Forceps |
| B3315881050 | Locking Fundus Tri-Max Grasping Forceps |
| B331588104545 | Locking Long Needle Nose Dissecting Forceps |
| B3315881045 | Locking Needle Nose Dissecting Forceps |
| B331588104445 | Locking Long Micro-Fenestrated Grasping Forceps |
| B3315881044 | Locking Micro-Fenestrated Grasping Forceps |
| B331588103545 | Locking Long Cup Tooth Dissecting Forceps |
| B3315881035 | Locking Cup Tooth Dissecting Forceps |
| B331588103445 | Locking Long Dolphin Nose Dissecting Forceps With Tissue Well |
| B3315881034 | Locking Dolphin Nose Dissecting Forceps With Tissue Well |
| B331588103345 | Locking Long Bullet Nose Dissecting Forceps |
| B3315881033 | Locking Bullet Nose Dissecting Forceps |
| B331588103245 | Locking Long Blunt Grasping Forceps |
| B3315881032 | Locking Blunt Grasping Forceps |
| B331588103045 | Locking Long Dolphin Nose Grasping Forceps |
| B3315881030 | Locking Dolphin Nose Grasping Forceps |
| B331588102445 | Locking Long Fenestrated Straight Grasping Forceps |
| B3315881024 | Locking Fenestrated Straight Grasping Forceps |
| B331588101845 | Locking Long Retrograde Grasping Forceps |
| B3315881018 | Locking Retrograde Grasping Forceps |
| B331588101245 | Locking Long 90° Degree Right Angle Dissecting Forceps |
| B3315881012 | Locking 90° Degree Right Angle Dissecting Forceps |
| B331588100745 | Locking Long Flat Blunt Dissecting Forceps |