FDA.reportPublic FDA data

ALLEVYN GENTLE BORDER 10X20CM

Primary DI
05000223476199
Brand
ALLEVYN GENTLE BORDER 10X20CM
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66800900
Catalog number
66800900
Device description
Silicone gel adhesive hydrocellular foam dressing
Published
2020-05-15
Public version status
New
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05000223476199PackageGS110In Commercial Distribution
05000223476205PackageGS16In Commercial Distribution
05000223476182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05000223476199050002234761995000223476199
05000223476205050002234762055000223476205
05000223476182050002234761825000223476182

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

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19
00500223504335NOVIX66027708660277082026-01-13
05000223502713No Sting Skin Prep66807691668076912025-11-26
05000223499389RENASYS66803107668031072025-09-23
05000223499396RENASYS66803106668031062025-09-23
05000223499402RENASYS66803105668031052025-09-23
05000223504267RENASYS66807737668077372025-09-23
05000223504274RENASYS66807736668077362025-09-23
05000223504281RENASYS66807735668077352025-09-23
05000223501686ALLEVYN™ Ag+66027663660276632025-08-12
05000223501693ALLEVYN™ Ag+66027664660276642025-08-12
05000223501709ALLEVYN™ Ag+66027665660276652025-08-12
05000223501808ALLEVYN™ Ag+66027669660276692025-08-12
05000223501815ALLEVYN™ Ag+66027670660276702025-08-12
05000223503178ALLEVYN COMPLETE CARE66807697668076972025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479282179McKessonMCKESSON MEDICAL-SURGICAL INC.NAD2026-03-17
06974795053920MEDLOTHenan Maidingkang Medical Technology Co., Ltd.NAD2026-03-13
30885632495469HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495851HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495875HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496742HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
06974843740574MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740581MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740598MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740604MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740741MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740758MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740765MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740772MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740789MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740796MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740802MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740819MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740826MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740833MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740840MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740857MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740864MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740871MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740888MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740895MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740901MemGardDalian Orientech Co.,LtdNAD2026-03-10