FDA.reportPublic FDA data

PremierPro

Primary DI
10818566017564
Brand
PremierPro
Company
SVS LLC
Model
3631
Catalog number
3631
Device description
Maternity Pad, 10.5"x4", 16/bg
Published
2020-08-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHDPad, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566017564PackageGS112In Commercial Distribution
00818566017567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601756410818566017564
00818566017567008185660175678185660175670818566017567

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
831375089
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

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00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2026-02-18
20810042482351CoraCoraHHD2026-02-16
20810042482368CoraCoraHHD2026-02-16
00050428057186CVSHealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-02-04
00050428073421CVSHealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-02-04
00050428080863CVSHealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-02-04
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