FDA UDI In Commercial Distribution 🇺🇸 United States

MYONE SAMPLER E66/47C

DI: 00726893512771 · Model: MY-E66/47C-S02 · GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2

Basic Information

Brand Name
MYONE SAMPLER E66/47C
Primary DI
00726893512771
Version / Model
MY-E66/47C-S02
Company Name
GLOBAL PROTECTION CORP.
Labeler DUNS
364614362
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2023-04-24
Public Version
2
Public Version Date
2023-11-07
Public Version Status
Update
Public Device Record Key
4510fbf4-8bcc-4407-89d7-9fab00399611

Device Description

2 Lubricated Latex Condoms

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
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
No
Sterilization Prior Use
No

Product Codes

Code Name
HIS Condom

GMDN Terms

Code Name
45138 Basic male condom, Hevea-latex

Identifiers

Type ID
Unit of Use 80726893512777
Primary 00726893512771