FDA.report

DeRoyal

Primary DI
00749756009362
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M3006
Catalog number
M3006
Device description
Elbow Protector
Published
2021-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00749756009362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756009362007497560093627497560093620749756009362

GMDN Terms

TermDefinition
Arm 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 from friction and knocks against objects. It is typically made from soft padded materials and is held in place with bands or straps around the arm or can be elastic tubular in design so that it slides over the arm. It is typically used by persons that have tendencies for 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(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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