FDA.reportPublic FDA data

InterDry

Primary DI
00311701068726
Brand
InterDry
Company
COLOPLAST CORP.
Model
7910
Catalog number
7910
Device description
InterDry. Moisture Wicking Fabric with Antimicrobial Silver. 144 in by 10 in
Published
2021-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
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
00311701068726PackageGS110In Commercial Distribution
00311701068825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00311701068726003117010687263117010687260311701068726
00311701068825003117010688253117010688250311701068825

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
Length144Inch
Width10Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
847436391
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00311701069525InterDry791279122021-04-09
00311701069730InterDry791579152021-04-09
00311701069426InterDry791279122021-04-09
00311701069938InterDry791579152021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
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10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
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