FDA.report

"Deluxe Suede Hammer Toe Crest, Large, Right, 3pcs/bag "

Primary DI
00614464929045
Brand
"Deluxe Suede Hammer Toe Crest, Large, Right, 3pcs/bag "
Company
Silipos Holding LLC
Model
92904
Published
2022-08-05
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

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614464929045PrimaryGS10

GMDN Terms

TermDefinition
General-purpose medical foam padding, reusableA roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
056112948
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
true
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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00614464040153Softzone Full Length Insole, Large, 1pair/box40152022-08-24
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