FDA.reportPublic FDA data

CUTICERIN 10X10CM

Primary DI
05000223456351
Brand
CUTICERIN 10X10CM
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66045564
Catalog number
66045564
Device description
Impregnated Gauze Dressing
Published
2020-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K842967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842967000AQUAPHOR R GAUZEBeiersdorf, Inc.1984-11-08FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05000223456368PackageGS110In Commercial Distribution
05000223456375PackageGS112In Commercial Distribution
05000223456351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05000223456368050002234563685000223456368
05000223456375050002234563755000223456375
05000223456351050002234563515000223456351

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Regulatory Flags#

DUNS number
216344051
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05000223482589CICA CARE66801491668014912026-04-30
05000223502157CICA CARE66803184668031842026-04-30
05000223502270ACTICOAT Flex66027686660276862026-04-29
05000223502300ACTICOAT Flex66027687660276872026-04-29
05000223502331ACTICOAT Flex66027688660276882026-04-29
05000223502249ACTICOAT Flex66027685660276852026-04-28
05000223502218ACTICOAT FLEX66027684660276842026-03-26
05000223503727ACTICOAT Flex66027683660276832026-03-26
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117737COVRSITE5971430059714300 / 597144002026-01-19
00040565117690COVRSITE5971400059714000 / 597141002026-01-19
00040565120249COVRSITE59715000597150002026-01-19
00040565120263COVRSITE59715100597151002026-01-19
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19
05000223494643PICO66022022660220222018-08-23
05000223494650PICO66022023660220232018-08-23

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Primary DI, Brand, Company table
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00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
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10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
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00850087488259CeeportCEEPORT INC.FRO2026-05-29
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10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
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