FDA.report

WALGREENS

Primary DI
06049022126262
Brand
WALGREENS
Company
WALGREEN CO.
Model
107281
Device description
Compression Sleeve - Calf S/M
Published
2020-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IQIOrthosis, Limb Brace

Product Code Classifications

CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10049022126265PackageGS124In Commercial Distribution
00049022126268PrimaryGS10
06049022126262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902212626510049022126265
00049022126268000490221262680490221262680049022126268
06049022126262060490221262626049022126262

GMDN Terms

TermDefinition
Tubular support bandage, non-latex, reusableA tubular, elastic 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-patient, reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-877-833-3324consumerrelations.pq@walgreens.com

Regulatory Flags

DUNS number
008965063
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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