FDA UDI In Commercial Distribution 🇺🇸 United States

Royal

DI: 00850012584124 · Model: Royal Strawberry Condoms Box of 20 · M3 Global Enterprises, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Royal
Primary DI
00850012584124
Version / Model
Royal Strawberry Condoms Box of 20
Company Name
M3 Global Enterprises, LLC
Labeler DUNS
080373674
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-21
Public Version
1
Public Version Date
2019-10-29
Public Version Status
New
Public Device Record Key
5c67b420-805c-4e75-af7a-9e5b0c1484fb

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HIS Condom

GMDN Terms

Code Name
45138 Basic male condom, Hevea-latex

Identifiers

Type ID
Primary 00850012584124