FDA.reportPublic FDA data

IV Clear 10x12cm notch dressing with securement strips

Primary DI
00825439016626
Brand
IV Clear 10x12cm notch dressing with securement strips
Company
Covalon Technologies Ltd
Model
7601012N
Device description
Antimicrobial clear silicone adhesive dressing
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112549000IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERCovalontechnologies, Inc.2012-05-04FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825439016626PackageGS125In Commercial Distribution
10825439016623PackageGS14In Commercial Distribution
00825439016633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439016626008254390166268254390166260825439016626
1082543901662310825439016623
00825439016633008254390166338254390166330825439016633

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial synthetic polymer semi-permeable film dressing, adhesiveA sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent. It is a thin, clear film made of synthetic polymer with a pressure-sensitive adhesive on one side that may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions, ulcers, burns, lacerations, abrasions, device insertion sites, and donor/graft sites. It may also be used to secure to skin other devices (e.g., catheters, drains, leads, ports). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
206936101
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00825439011188ColActive® Plus 2"x2"55502202022-11-30
00825439011218ColActive® Plus 4"x4"55504402022-11-30
00825439011249ColActive® Plus 7"x7"55507702022-11-30
00825439011270ColActive® Plus Ag 2"x2"55512202022-11-30
00825439011300ColActive® Plus Ag 4"x4"55514402022-11-30
00825439011331ColActive® Plus Ag 7"x7"55517702022-11-30
00825439017241ColActive® Plus Powder80P00012022-11-30
00825439017265ColActive® Plus Powder Ag81P00012022-11-30
00825439012062MediClear™ Scar 10x10900101090010102023-07-14
00825439012260MediClear™ Scar 4x4900040490004042023-07-14
00825439012291MediClear™ Scar 6x7900060790006072023-07-14
00825439012321MediClear™ Scar 6x30900063090006302023-07-14
00825439012789MediClear™ PreOp 70010122018-04-30
00825439012819MediClear PreOp70006302022-12-01
00825439012994MediClear PreOp70006252022-12-01
00825439016169MediClear™ PreOp70008302018-05-18
00825439012871MediClear™ PreOp70006072018-04-30
00825439010136IV Clear 4x4 with crosshairTWBD10112022-11-30
00825439010334SurgiClear 4x4TWBD10222022-12-01
00825439010464IV Clear 4x4TWBD10132022-11-30

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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
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