FDA.reportPublic FDA data

PremierPro

Primary DI
00818566017314
Brand
PremierPro
Company
PRESTIGE AMERITECH, LTD.
Model
7004
Catalog number
7004
Device description
"Water Resistant Padding, 4"" x 2.6 yds, 12 rolls/bx, 6 bx/cs"
Published
2020-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818566017314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818566017314008185660173148185660173140818566017314

GMDN Terms#

Term, Definition table
TermDefinition
Cast/bandage waterproof bathing cover, single-useA device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
199692794
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29
00811220030063PremierPro881988192020-08-29
00811220030278PremierPro635563552020-08-02
00811220030308PremierPro500150012020-06-26
00811220030315PremierPro500250022020-06-26
00811220030322PremierPro500350032020-06-26
00811220030339PremierPro500450042020-06-26
00811220030346PremierPro500550052020-06-26
00811220030360PremierPro Lancet755275522018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
007073874969683M™3M Deutschland GmbHITG2026-05-08
007073874969753M™3M Deutschland GmbHITG2026-05-08
007073874969823M™3M Deutschland GmbHITG2026-05-08
007073874969993M™3M Deutschland GmbHITG2026-05-08
087114280529303M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529543M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529923M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530363M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530503M™ Scotchcast™Solventum US LLCITG2026-04-18
10080196284191MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10080196832330MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10192253045864WebrilCardinal Health 200, LLCITG2025-09-23
10192253045871WebrilCardinal Health 200, LLCITG2025-09-23
10192253045888WebrilCardinal Health 200, LLCITG2025-09-23
10192253045925WebrilCardinal Health 200, LLCITG2025-09-23
00840117344396"CurPro Undercast Padding , 100% Polyester, 3"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344402"CurPro Undercast Padding, 100% Polyester, 4"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344419"CurPro Undercast Padding, 100% Polyester, 6"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344426"CurPro Undercast Padding, 100% Polyester, 8"" x 4 yd"Dynarex CorporationITG2025-06-05
10885632106545MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-16
10885632106514MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10885632106538MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10197106823019CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
10080196745616MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196745661MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196284184MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10080196824779MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10197106447994CARDINAL HEALTHCardinal Health 200, LLCITG2023-10-12
307073877914153M™ Scotchcast™3M COMPANYITG2022-12-08
307073877914223M™ Scotchcast™3M COMPANYITG2022-12-08