FDA.report

ULNAR NERVE PROTECTOR

Primary DI
G0648317270016631
Brand
ULNAR NERVE PROTECTOR
Company
POSITION HEALTH, LLC
Model
831727001663
Catalog number
831727001663
Device description
ULNAR NERVE PROTECTOR, Arm Friction/Impact Protector, One Size, Set of 2
Published
2022-12-09
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
false

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G0648317270016631PrimaryHIBCC0
G0648317270016630Unit of UseHIBCC0

GMDN Terms

TermDefinition
Arm friction/impact protectorA device designed to be worn over some length of the arm (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb and its skin from friction and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the arm, or has a tubular sleeve design; it is not dedicated to the elbow. It is typically used by persons who have thinning skin or skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-254-5438info@positionhealthusa.com

Regulatory Flags

DUNS number
116685742
Device count
2
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
false
Sterilization required before use
false

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G064208317270091511CastWedge™20831727009151208317270091512022-12-09
G064208317270092051CastWedge™20831727009205208317270092052022-12-09
G064208317270092501CastWedge™ 20831727009250208317270092502022-12-09
G064208317270093041CastWedge™20831727009304208317270093042022-12-09
G064208317270097860HEELIFT® 20831727009786208317270097862022-12-09
G0648317270013731TurnAssist®8317270013738317270013732022-12-09
G0648317270013970TurnAssist®8317270013978317270013972022-12-09
G0648317270038580HEELIFT GLIDE® 8317270038588317270038582022-12-09
G0648317270041140HEEL/ELBOW PROTECTOR8317270041148317270041142022-12-09
G0648317270046640KNEE SEPARATOR8317270046648317270046642022-12-09
G0648317270052030HEELIFT GLIDE® Ultra8317270052038317270052032022-12-09
G0648317270053020HEELIFT AFO® Ultra 8317270053028317270053022022-12-09
G0648317270054010HEELIFT GLIDE® Ultra8317270054018317270054012022-12-09
G0648317270055000HEELIFT GLIDE® Ultra8317270055008317270055002022-12-09
G0648317270062790HEELIFT GLIDE® 8317270062798317270062792022-12-09
G0648317270064530HEELIFT GLIDE® 8317270064538317270064532022-12-09
G0648317270064600HEELIFT GLIDE® 8317270064608317270064602022-12-09
G0648317270064770HEELIFT GLIDE® 8317270064778317270064772022-12-09

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