Bone Access Kit 3404

GUDID B87534040

Convenience kit no Lidocaine

Custom Interventional Pain Management, LLC

Bone marrow biopsy procedure kit
Primary Device IDB87534040
NIH Device Record Key6f0271ac-a07f-4367-b0d7-90cbb669a0e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Access Kit
Version Model Number3404
Catalog Number3404
Company DUNS030406006
Company NameCustom Interventional Pain Management, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB87534040 [Primary]

FDA Product Code

PXOBone Marrow Biopsy Tray

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


[B87534040]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

On-Brand Devices [Bone Access Kit]

B875TRAPLID0Convenience kit with Lidocaine
B875CTDLID0Convenience kit with Lidocaine
B87534040Convenience kit no Lidocaine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.