FDA UDI In Commercial Distribution 🇺🇸 United States

Dornier MedTech

DI: 00810116023028 · Model: Equipment Cover (Movement Footswitch) · DORNIER MEDTECH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Dornier MedTech
Primary DI
00810116023028
Version / Model
Equipment Cover (Movement Footswitch)
Catalog Number
FTSXCVRLG
Company Name
DORNIER MEDTECH AMERICA, INC.
Labeler DUNS
130789944
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-17
Public Version
1
Public Version Date
2020-03-25
Public Version Status
New
Public Device Record Key
b0f9084a-82c9-455c-995a-c7213c54812e

Device Description

Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26”

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IZI System, X-Ray, Angiographic

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 10810116023025
Primary 00810116023028