FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10884389931950
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
MSC7348EP
Catalog number
MSC7348EP
Device description
DRESSING, ALGINATE, MAXORB II, 4""X8""
Published
2021-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884389931954PackageGS15In Commercial Distribution
40884389931951PackageGS150In Commercial Distribution
10884389931950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088438993195430884389931954
4088438993195140884389931951
1088438993195010884389931950

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing. Avoid excessive heat
Storage Environment Temperature00

Contacts#

Phone, Email table
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196321445MEDLINEMDS30804MDS308042026-09-24
30080196293548MEDLINENON28625NON286252026-09-24
40080196921554GeminiGEM5172GEM51722016-10-14
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10080196632381MEDLINE INDUSTRIES, INC.MSC7344EPMSC7344EP2021-05-18
10193489104516MEDLINEMRPP2910MRPP29102024-07-11
10884389931943MEDLINE INDUSTRIES, INC.MSC7318EPMSC7318EP2021-05-18
20080196184085GeminiGEM3118SGEM3118S2016-10-14
20080196184283GeminiGEM3130SGEM3130S2016-10-14
20080196184344GeminiGEM3136SGEM3136S2016-10-14
20080196184498GeminiGEM3140SGEM3140S2016-10-14
20080196184559GeminiGEM3145SGEM3145S2016-10-14
20080196184610GeminiGEM3148SGEM3148S2016-10-14
20080196184696GeminiGEM3154SGEM3154S2016-10-14
20080196184986GeminiGEM4118SGEM4118S2020-12-22
20080196921185GeminiGEM1148GEM11482016-10-14
20080196921192GeminiGEM1154GEM11542016-10-14
20080196921307GeminiGEM3118GEM31182016-10-14
20080196921321GeminiGEM3124GEM31242016-10-14
20080196921338GeminiGEM3130GEM31302016-10-14

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