FDA UDI In Commercial Distribution 🇺🇸 United States

Advanced Imaging Modality (AIM) Sterilization Tray

DI: 00857387006008 · Model: 0233-032-301 · PARAGON MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Advanced Imaging Modality (AIM) Sterilization Tray
Primary DI
00857387006008
Version / Model
0233-032-301
Catalog Number
0233-032-301
Company Name
PARAGON MEDICAL, INC.
Labeler DUNS
609244454
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-22
Public Version
8
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
0bf0cc00-946e-4897-b2a7-e4535231d20c

Device Description

Advanced Imaging Modality (AIM) Sterilization Tray

Device Characteristics

Single Use
No
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", "Hydrogen Peroxide", "Ethylene Oxide"]

Product Codes

Code Name
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00857387006008

Customer Contacts