FDA UDI In Commercial Distribution 🇺🇸 United States

IMAGE DIAGNOSTICS INC

DI: 00850977007898 · Model: PRO KIT, CASE · IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
IMAGE DIAGNOSTICS INC
Primary DI
00850977007898
Version / Model
PRO KIT, CASE
Catalog Number
A800-0310
Company Name
IMAGE DIAGNOSTICS, INC.
Labeler DUNS
608235214
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2021-12-14
Public Version
2
Public Version Date
2023-06-09
Public Version Status
Update
Public Device Record Key
a09dc88a-3a41-43d8-9c20-09bac31adef1

Device Description

IDI,PROTEGO "PRO" PROCEDURE KIT,CASE OF 25 POUCHES,#A800-0310

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
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
No

Product Codes

Code Name
MMP Cover, Barrier, Protective

GMDN Terms

Code Name
40655 Basic diagnostic x-ray system table, powered

Identifiers

Type ID
Unit of Use 00850977007881
Primary 00850977007898

Customer Contacts