FDA.report

EXU-DRY ARM/HAND DRESSING CTN 20

Primary DI
30040565118681
Brand
EXU-DRY ARM/HAND DRESSING CTN 20
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
5999LPA
Catalog number
5999LPA
Device description
EXU-DRY* Anti-Shear Wound Dressing is a one-piece, multilayer, highly-absorbent, non-adherent wound dressing designed to minimize trauma and save nursing time. Anti-shear layer helps reduce friction and shearing
Published
2020-04-09
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

Related Records

Product Codes

CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30040565118681PackageGS120In Commercial Distribution
00040565118680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3004056511868130040565118681
00040565118680000405651186800405651186800040565118680

GMDN Terms

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

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

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