FDA.report

Medline

Primary DI
20080196778840
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MSC1104
Catalog number
MSC1104
Device description
DRESSING,FOAM,ISLAND,RND,FENSTRATED,4"
Published
2023-01-04
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

Contact Domains

Product Codes

CodeName
NADDressing, wound, occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20080196778840PackageGS130In Commercial Distribution
40080196778844PackageGS1120In Commercial Distribution
10080196778843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2008019677884020080196778840
4008019677884440080196778844
1008019677884310080196778843

GMDN Terms

TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from light. Store in a cool, dry place.

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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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
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20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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