Primary Device ID | B167110T001270 |
NIH Device Record Key | b5336780-44b7-46db-a794-10b26e87d621 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CURE OPEL-C |
Version Model Number | 11-0T001-27 |
Company DUNS | 182698477 |
Company Name | MEDITECH SPINE, 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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B167110T001270 [Primary] |
KWQ | Appliance, fixation, spinal intervertebral body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
[B167110T001270]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-23 |
Device Publish Date | 2020-03-15 |