Primary Device ID | H9803166160 |
NIH Device Record Key | b1be2124-0629-4644-bf41-a45c6d5004f5 |
Commercial Distribution Discontinuation | 2020-06-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Version Model Number | 316.616 |
Catalog Number | 316616 |
Company DUNS | 832637081 |
Company Name | SYNTHES (U.S.A.) LP |
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 | 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)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10887587038162 [Primary] |
HIBCC | H9803166160 [Secondary] |
HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
Steralize Prior To Use | true |
Device Is Sterile | false |
[H9803166160]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-06-29 |
Device Publish Date | 2018-09-21 |
H981023060100 - NA | 2024-07-12 6.0MM PELVIC ROD-LEFT |
H981023060120 - NA | 2024-07-12 6.0MM PELVIC ROD-RIGHT |
H981042006140 - Axon | 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH |
H981042006150 - Axon | 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH |
H981042006160 - Axon | 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH |
H981042006170 - Axon | 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH |
H981042006180 - Axon | 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH |
H981042006190 - Axon | 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH |