FDA.report

Ultra Thin Maxi Pads Without Wings

Primary DI
00840117328495
Brand
Ultra Thin Maxi Pads Without Wings
Company
DYNAREX CORPORATION
Model
1359
Device description
Not-Sterile
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HHDPad, Menstrual, Unscented

Product Code Classifications

CodeDeviceSpecialtyClass
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117328495PackageGS1250In Commercial Distribution
00840117313811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117328495008401173284958401173284950840117328495
00840117313811008401173138118401173138110840117313811

GMDN Terms

TermDefinition
Menstrual pad, unscentedA non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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