FDA.reportPublic FDA data

ALLEVYN Gentle Border 7in x 7in

Primary DI
05000223464165
Brand
ALLEVYN Gentle Border 7in x 7in
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66800280
Catalog number
66800280, 66800273
Device description
ALLEVYN Gentle Border 7in x 7in Silicone gel adhesive hydrocellular foam dressing
Published
2019-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05000223464004PackageGS110In Commercial Distribution
05000223464011PackageGS18In Commercial Distribution
05000223464165PackageGS14In Commercial Distribution
05000223464172PackageGS14In Commercial Distribution
05000223463991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05000223464004050002234640045000223464004
05000223464011050002234640115000223464011
05000223464165050002234641655000223464165
05000223464172050002234641725000223464172
05000223463991050002234639915000223463991

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gelA sterile wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
216344051
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
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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10192253038828KendallCardinal Health 200, LLCNAD2025-11-21
10192253038866KendallCardinal Health 200, LLCNAD2025-11-21
10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
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10197344162505MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
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10080196738533MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-13
10192253046076KerlixCardinal Health 200, LLCNAD2025-09-23
10192253046083KerlixCardinal Health 200, LLCNAD2025-09-23
10193489036176MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-07-28
10197344155620MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-07-28
10198956074965CARDINAL HEALTHCardinal Health 200, LLCNAD2025-06-13
10080196743056MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-05-07
10080196743063MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-05-07
10080196743070MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-05-07
10080196743087MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-05-07