FDA UDI In Commercial Distribution 🇺🇸 United States

PREFERRED MEDICAL PRODUCTS, LLC

DI: 00680211003054 · Model: IP-1522-C · PREFERRED MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
PREFERRED MEDICAL PRODUCTS, LLC
Primary DI
00680211003054
Version / Model
IP-1522-C
Catalog Number
IP-1522-C
Company Name
PREFERRED MEDICAL PRODUCTS, LLC
Labeler DUNS
161770292
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-11
Public Version
1
Public Version Date
2023-01-19
Public Version Status
New
Public Device Record Key
1489dc27-8479-4fb7-b1ef-4ddc02d5b81a

Device Description

STERILE DISPOSABLE EQUIPMENT COVER - COIL COVER 15" X 22" STERILE, TAPE, REINFORCED HOLES

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 10680211003051
Primary 00680211003054
Package 30680211003055

Premarket Submissions

Submission Number Supplement Number
K863853 000