FDA.reportPublic FDA data

Bone Access Kit

Primary DI
B87534040
Brand
Bone Access Kit
Company
Custom Interventional Pain Management, LLC
Model
3404
Catalog number
3404
Device description
Convenience kit no Lidocaine
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PXOBone Marrow Biopsy Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXOBone Marrow Biopsy TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B87534040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy procedure kitA packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
030406006
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B875700Individual Ancillary Item Kit70702023-09-11
B87560LID0Discseel60LID60LID2023-08-15
B875DSCLID0DiscseelDSCLIDDSCLID2023-08-15
B875170Epidural Anesthesia Kit17172023-07-19
B87517LID0Epidural Anesthesia Kit17LID17LID2023-07-19
B875180Epidural Anesthesia Kit18182023-07-19
B87518LID0Epidural Anesthesia Kit18LID18LID2023-07-19
B875200Epidural Anesthesia Kit20202023-07-19
B87520LID0Epidural Anesthesia Kit20LID20LID2023-07-19
B875220Epidural Anesthesia Kit22222023-07-19
B87522LID0Epidural Anesthesia Kit22LID22LID2023-07-19
B875300Nerve Block Tray30302023-07-19
B87530LID0Nerve Block Tray30LID30LID2023-07-19
B875310Custom Anesthesia Tray31312023-07-19
B87531LID0Custom Anesthesia Tray31LID31LID2023-07-19
B875400Continuous Regional Anesthesia Kit40402023-07-19
B87540LID0Continuous Regional Anesthesia Kit40LID40LID2023-07-19
B875410Spinal Anesthesia Kit41412023-07-19
B87541LID0Spinal Anesthesia Kit41LID41LID2023-07-19
B875500Refill Tray50502023-07-19

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