Primary Device ID | B54112113000 |
NIH Device Record Key | 3f67a41b-61d3-4591-bdb6-939f3bd56f4c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Wire Ladder Splint |
Version Model Number | Wire Ladder Splint |
Catalog Number | 1211300 |
Company DUNS | 626802540 |
Company Name | FARETEC, INC. |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com | |
Phone | 440-350-9510 |
colleen@faretec.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B54112113000 [Primary] |
NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-24 |
Device Publish Date | 2021-05-14 |
B54112113000 | Wire Ladder splint |
B54112114000 | 6 each wire ladder splint, 6 each gauze and 6 each safety pins. |