FDA UDI In Commercial Distribution 🇺🇸 United States

Del Medical/Universal

DI: 00858340006134 · Model: EV800T · Del Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Del Medical/Universal
Primary DI
00858340006134
Version / Model
EV800T
Company Name
Del Medical, Inc.
Labeler DUNS
078671236
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-04-15
Public Version
1
Public Version Date
2022-04-25
Public Version Status
New
Public Device Record Key
04b826a9-aa01-45ff-9d0a-67daf9a4e404

Device Description

The EV800T elevating table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. The EV800T is intended to be used with the DM-OTC18S auto-stitching system.

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IZZ Table, Radiographic, Non-Tilting, Powered

GMDN Terms

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

Identifiers

Type ID
Primary 00858340006134