FDA.report

Medline

Primary DI
20193489017684
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON7920
Catalog number
NON7920
Device description
DRESSING,BURN,9"X36",16PLY,STERILE,LF
Published
2021-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489017684PackageGS160In Commercial Distribution
10193489017687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348901768420193489017684
1019348901768710193489017687

GMDN Terms

TermDefinition
Cotton burn dressing, non-antimicrobialA covering designed to treat small to large patient burns. It is made of woven cotton impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, provide pain relief, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 1x1 m to 1x2 m), prefabricated shapes (e.g., vest) and may be body contoured; it does not include an antimicrobial agent(s). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep Dry

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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