FDA UDI In Commercial Distribution 🇺🇸 United States

Bone Access Kit

DI: B87534040 · Model: 3404 · Custom Interventional Pain Management, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Bone Access Kit
Primary DI
B87534040
Version / Model
3404
Catalog Number
3404
Company Name
Custom Interventional Pain Management, LLC
Labeler DUNS
030406006
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-19
Public Version
1
Public Version Date
2023-07-27
Public Version Status
New
Public Device Record Key
6f0271ac-a07f-4367-b0d7-90cbb669a0e9

Device Description

Convenience kit no Lidocaine

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
Yes
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
PXO Bone Marrow Biopsy Tray

GMDN Terms

Code Name
16833 Bone marrow biopsy procedure kit

Identifiers

Type ID
Primary B87534040