FDA UDI Not in Commercial Distribution 🇺🇸 United States

PenBoneB

DI: 08058341214435 · Model: PIP1810/50 · M.D.L. S.R.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
PenBoneB
Primary DI
08058341214435
Version / Model
PIP1810/50
Catalog Number
PIP1810/50
Company Name
M.D.L. S.R.L.
Labeler DUNS
447228586
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-07
Public Version
4
Public Version Date
2021-05-27
Public Version Status
Update
Public Device Record Key
ccbe65dc-f9a4-4c46-a5ab-d223884f906a
Distribution End Date
2021-04-26

Device Description

DISPOSABLE NEEDLE FOR BONE MARROW ASPIRATION 18Gx10/50mm

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DWO Needle, Biopsy, Cardiovascular

GMDN Terms

Code Name
46350 Bone marrow biopsy needle, single-use

Identifiers

Type ID
Primary 08058341214435