FDA.report

MEDLINE

Primary DI
20193489084655
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MSC9506LFYD
Catalog number
MSC9506LFYD
Device description
SUPPORT BANDAGE LF SIZE G 1YRD
Published
2024-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MHWDressing, compression

Product Code Classifications

CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489084655PackageGS130In Commercial Distribution
10193489084658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348908465520193489084655
1019348908465810193489084658

GMDN Terms

TermDefinition
Tubular support bandage, non-latex, single-useA tubular elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-use device.

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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