FDA.report

Panty Liner

Primary DI
00616784133638
Brand
Panty Liner
Company
DYNAREX CORPORATION
Model
1336
Device description
Panty Liners w/ Adhesive Tab 6"x17" (18g), Large
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
00616784133638PackageGS110In Commercial Distribution
00616784133621PrimaryGS10
00616784133614Unit of UseGS10
00810180842631Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784133638006167841336386167841336380616784133638
00616784133621006167841336216167841336210616784133621
00616784133614006167841336146167841336140616784133614
00810180842631008101808426318101808426310810180842631

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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