FDA UDI Not in Commercial Distribution 🇺🇸 United States

CARDINAL HEALTH

DI: 10885380096525 · Model: P413-03 · Cardinal Health 200, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CARDINAL HEALTH
Primary DI
10885380096525
Version / Model
P413-03
Catalog Number
P413-03
Company Name
Cardinal Health 200, LLC
Labeler DUNS
961027315
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-29
Public Version
4
Public Version Date
2024-02-19
Public Version Status
Update
Public Device Record Key
14cecc60-0bfe-48b3-b37d-16263904898b
Distribution End Date
2018-06-01

Device Description

1.3mm Ti Extended H-Plate 8 Holes 19mm Right Material: Ti-6AI-4V Titanium

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
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HWC Screw, fixation, bone
HRS Plate, fixation, bone

GMDN Terms

Code Name
61573 Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Identifiers

Type ID
Primary 10885380096525