FDA.report

Duragel Pin Liner, Uniform, 6mm, Medium

Primary DI
00614464182013
Brand
Duragel Pin Liner, Uniform, 6mm, Medium
Company
Silipos Holding LLC
Model
18201
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
IQODevice, Prosthesis Alignment

Product Code Classifications

CodeDeviceSpecialtyClass
IQODevice, Prosthesis AlignmentPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614464182013PrimaryGS10

GMDN Terms

TermDefinition
External limb prosthesis socket linerA flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).

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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