FDA.reportPublic FDA data

SurgiClear 4x7

Primary DI
00825439010259
Brand
SurgiClear 4x7
Company
Covalon Technologies Ltd
Model
TWBD1017
Device description
Antimicrobial clear silicone adhesive dressing
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
K121819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121819000SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERCovalontechnologies, Inc.2012-08-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825439010266PackageGS125In Commercial Distribution
10825439010263PackageGS14In Commercial Distribution
00825439010259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439010266008254390102668254390102660825439010266
1082543901026310825439010263
00825439010259008254390102598254390102590825439010259

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
Length7Centimeter
Width4Centimeter

Storage And Handling#

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

Regulatory Flags#

DUNS number
206936101
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08