FDA UDI In Commercial Distribution 🇺🇸 United States

PREFERRED MEDICAL PRODUCTS, LLC

DI: 00680211000244 · Model: C-ARM 90 · PREFERRED MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
PREFERRED MEDICAL PRODUCTS, LLC
Primary DI
00680211000244
Version / Model
C-ARM 90
Catalog Number
C-ARM 90
Company Name
PREFERRED MEDICAL PRODUCTS, LLC
Labeler DUNS
161770292
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-30
Public Version
6
Public Version Date
2021-12-22
Public Version Status
Update
Public Device Record Key
a6076dd4-f42e-48d5-aaa3-066d4422bd51

Device Description

STERILE DISPOSABLE EQUIPMENT COVER - C-ARM DRAPE 36" X 90" - 4 POLY STRAPS

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
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
JAA System, X-Ray, Fluoroscopic, Image-Intensified

GMDN Terms

Code Name
47783 Patient surgical drape, single-use

Identifiers

Type ID
Package 10680211000241
Primary 00680211000244

Premarket Submissions

Submission Number Supplement Number
K863853 000