Primary Device ID | B13092501 |
NIH Device Record Key | b4bf186e-15ce-4236-959a-2d12cefc9f66 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Checkpoint Edge Nerve Cutting Kit |
Version Model Number | 9250 |
Catalog Number | 9250 |
Company DUNS | 832575364 |
Company Name | Checkpoint Surgical, 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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 2163789107 |
regulatory@checkpointsurgical.com | |
Phone | 2163789107 |
regulatory@checkpointsurgical.com | |
Phone | 2163789107 |
regulatory@checkpointsurgical.com | |
Phone | 2163789107 |
regulatory@checkpointsurgical.com | |
Phone | 2163789107 |
regulatory@checkpointsurgical.com | |
Phone | 2163789107 |
regulatory@checkpointsurgical.com | |
Phone | 2163789107 |
regulatory@checkpointsurgical.com |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B13092500 [Primary] |
HIBCC | B13092501 [Package] Contains: B13092500 Package: pouch [1 Units] In Commercial Distribution |
HIBCC | B13092502 [Package] Package: box [1 Units] In Commercial Distribution |
HIBCC | B13092503 [Package] Contains: B13092502 Package: shipping carton [1 Units] In Commercial Distribution |
HAO | Instrument, Surgical, Non-Powered |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-05-17 |
Device Publish Date | 2022-05-09 |
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