FDA.reportPublic FDA data

InterDry

Primary DI
00311701069525
Brand
InterDry
Company
COLOPLAST CORP.
Model
7912
Catalog number
7912
Device description
InterDry. Moisture Wicking Fabric with Antimicrobial Silver. 36 in by 10 in.
Published
2021-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110715000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110715000INTERDRY SILVERMilliken Healthcare Products, LLC2011-11-04FRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00311701069358PackageGS110In Commercial Distribution
00311701069426PackageGS13In Commercial Distribution
00311701069525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00311701069358003117010693583117010693580311701069358
00311701069426003117010694263117010694260311701069426
00311701069525003117010695253117010695250311701069525

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial skin friction/moisture control fabric, single-patient reusableA non-sterile absorbent textile material intended to be applied in skin folds or where skin-to-skin contact occurs (e.g., armpits, under the breasts, stomach, groin, and between fingers or toes) to prevent or reduce skin-to-skin friction, moisture, and irritation/inflammation; it is not intended to be used on open wounds. It is made of natural and/or synthetic materials and contains an antimicrobial agent [e.g., silver (Ag)]. This is a single-patient reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Inch
Width10Inch

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
847436391
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932767521Insertion ToolNTER01NTER012024-09-27
05708932767545Insertion ToolNTER01NTER012024-09-27
05708932286350Manhood27-4200-B / 5071027-4200-B / 507102020-12-16
00311701068825InterDry791079102021-04-09
00311701069730InterDry791579152021-04-09
00311701068726InterDry791079102021-04-09
00311701069426InterDry791279122021-04-09
00311701069938InterDry791579152021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536925007BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925014BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925021BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925038BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925045BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925052BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925069BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925076BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925083BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925090BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925113BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925120BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925137BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925144BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925151BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925168BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219459MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06