FDA UDI In Commercial Distribution 🇺🇸 United States

PREFERRED MEDICAL PRODUCTS, LLC

DI: 00680211000206 · Model: C-ARM 54 · PREFERRED MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1

Basic Information

Brand Name
PREFERRED MEDICAL PRODUCTS, LLC
Primary DI
00680211000206
Version / Model
C-ARM 54
Catalog Number
C-ARM 54
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
e54625bb-8de6-43a3-87a8-9548d5fe63b1

Device Description

STERILE DISPOSABLE EQUIPMENT COVERS - C-ARM DRAPE - 36" X 28" BAND BAG WITH 54" TAIL AND 36" X 20" BAND BAG

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 50680211000201
Primary 00680211000206
Package 40680211000204
Package 10680211000203

Premarket Submissions

Submission Number Supplement Number
K863853 000