FDA.report

Panty Liner

Primary DI
00616784133539
Brand
Panty Liner
Company
DYNAREX CORPORATION
Model
1335
Device description
Panty Liners, Sq. End. w/ Adhesive Tab 4"x11" (21g), Medium
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications

CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784133539PackageGS110In Commercial Distribution
00616784133522PrimaryGS10
00616784133515Unit of UseGS10
00810180842624Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784133539006167841335396167841335390616784133539
00616784133522006167841335226167841335220616784133522
00616784133515006167841335156167841335150616784133515
00810180842624008101808426248101808426240810180842624

GMDN Terms

TermDefinition
Incontinence pants linerA disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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