FDA.report

ALLEVYN Ag Small Sacrum

Primary DI
05000223459871
Brand
ALLEVYN Ag Small Sacrum
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66020983
Catalog number
66020983
Device description
ALLEVYN Ag Small Sacrum Silver Wound Dressing
Published
2019-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05000223459871PackageGS110In Commercial Distribution
05000223459888PackageGS18In Commercial Distribution
05000223459864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05000223459871050002234598715000223459871
05000223459888050002234598885000223459888
05000223459864050002234598645000223459864

GMDN Terms

TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA sterile wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for trauma to the wound and/or causing pain upon removal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Regulatory Flags

DUNS number
216344051
Device count
1
DM exempt
false
Premarket exempt
false
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 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

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