Primary Device ID | B167900430200 |
NIH Device Record Key | ade2ab2c-2fc5-4d89-abdf-2fda6814a86a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CURE ACP |
Version Model Number | 900-430-20 |
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 | 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 | B167900430200 [Primary] |
KWQ | Appliance, fixation, spinal intervertebral body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B167900430200]
Moist Heat or Steam Sterilization
[B167900430200]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-11-22 |
Device Publish Date | 2017-10-11 |
B167S1700435100 | S1-700-435-10 |
B167S1700430200 | S1-700-430-20 |
B167S1700430180 | S1-700-430-18 |
B167S1700430160 | S1-700-430-16 |
B167S1700430140 | S1-700-430-14 |
B167S1700430120 | S1-700-430-12 |
B167S1700430100 | S1-700-430-10 |
B167900430600 | 900-430-60 |
B167900430550 | 900-430-55 |
B167900430500 | 900-430-50 |
B167900430450 | 900-430-45 |
B167900430400 | 900-430-40 |
B167900430350 | 900-430-35 |
B167900430300 | 900-430-30 |
B167900430250 | 900-430-25 |
B167900430200 | 900-430-20 |
B167700455000 | 700-455-00 |
B167700436000 | 700-436-00 |
B167700435100 | 700-435-10 |
B167700430200 | 700-430-20 |
B167700430180 | 700-430-18 |
B167700430160 | 700-430-16 |
B167700430140 | 700-430-14 |
B167700430120 | 700-430-12 |
B167700430100 | 700-430-10 |