FDA.reportPublic FDA data

ALLEVYN Gentle Border Sacrum

Primary DI
05000223483081
Brand
ALLEVYN Gentle Border Sacrum
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66020413
Catalog number
66020413, 66800898
Device description
ALLEVYN Gentle Border Sacrum Silicone gel adhesive hydrocellular sacrum 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
05000223476137PackageGS110In Commercial Distribution
05000223476144PackageGS16In Commercial Distribution
05000223483081PackageGS110In Commercial Distribution
05000223483098PackageGS16In Commercial Distribution
05000223476120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05000223476137050002234761375000223476137
05000223476144050002234761445000223476144
05000223483081050002234830815000223483081
05000223483098050002234830985000223483098
05000223476120050002234761205000223476120

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
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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
10197344169344MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
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10197344169368MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169375MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344162505MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162529MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
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10197344162543MEDLINEMEDLINE 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