FDA UDI In Commercial Distribution 🇺🇸 United States

DynaCare Tampons, Super Plus, Cardboard Applicator

DI: 00840117328761 · Model: 1355SP · Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20

Basic Information

Brand Name
DynaCare Tampons, Super Plus, Cardboard Applicator
Primary DI
00840117328761
Version / Model
1355SP
Company Name
Dynarex Corporation
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2024-03-07
Public Version
4
Public Version Date
2025-08-18
Public Version Status
Update
Public Device Record Key
5fc2c590-e7ea-4fe8-8266-8f1fa32e9961

Device Description

Unscented, Free Of Dyes & Perfumes

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HEB Tampon, Menstrual, Unscented

GMDN Terms

Code Name
35694 Menstrual tampon, unscented

Identifiers

Type ID
Unit of Use 00810180840637
Primary 00840117328761
Package 00840117328433

Premarket Submissions

Submission Number Supplement Number
K191666 000
K241064 000