FDA.reportPublic FDA data

SOFT SOCK ®

Primary DI
00674854000136
Brand
SOFT SOCK ®
Company
Thuasne LLC
Model
1SP1XWMD
Catalog number
1SP1XWMD
Device description
SOFT SOCK LTWT XWMD FITS SIZE #4+ X 16-20
Published
2018-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00674854000136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00674854000136006748540001366748540001360674854000136

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

Regulatory Flags#

DUNS number
094737173
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721734050016THERAFIRM SINGLES®T500E0105DOKHC2030BS2018-12-31
00721734050061THERAFIRM SINGLES®T500E0130DOKHC2030SS2018-12-31
00721734050078THERAFIRM SINGLES®T500E0230DOKHC2030SM2018-12-31
00721734050085THERAFIRM SINGLES®T500E0330DOKHC2030SL2018-12-31
00721734050092THERAFIRM SINGLES®T500E0430DOKHC2030SXL2018-12-31
00721734050115THERAFIRM SINGLES®T501E0105DOKHO2030BS2018-12-31
00721734050122THERAFIRM SINGLES®T501E0205DOKHO2030BM2018-12-31
00721734050139THERAFIRM SINGLES®T501E0305DOKHO2030BL2018-12-31
00721734050146THERAFIRM SINGLES®T501E0405DOKHO2030BXL2018-12-31
00721734050160THERAFIRM SINGLES®T501E0130DOKHO2030SS2018-12-31
00721734050177THERAFIRM SINGLES®T501E0230DOKHO2030SM2018-12-31
00721734050184THERAFIRM SINGLES®T501E0330DOKHO2030SL2018-12-31
00721734050191THERAFIRM SINGLES®T501E0430DOKHO2030SXL2018-12-31
00721734050214THERAFIRM SINGLES®T502E0105DOTHC2030BS2018-12-31
00721734050221THERAFIRM SINGLES®T502E0205DOTHC2030BM2018-12-31
00721734050238THERAFIRM SINGLES®T502E0305DOTHC2030BL2018-12-31
00721734050245THERAFIRM SINGLES®T502E0405DOTHC2030BXL2018-12-31
00721734050269THERAFIRM SINGLES®T502E0130DOTHC2030SS2018-12-31
00721734050276THERAFIRM SINGLES®T502E0230DOTHC2030SM2018-12-31
00721734050283THERAFIRM SINGLES®T502E0330DOTHC2030SL2018-12-31

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