ESPIRE

Primary DI
05056394325873
Brand
ESPIRE
Company
HUGH STEEPER LIMITED
Model
Espire Elbow Basic- Right- Jet Black- Medial Dial-
Catalog number
EEB-RJMD
Published
2023-07-05
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
IRDJoint, Elbow, External Limb Component, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
IRDJoint, Elbow, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056394325873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05056394325873050563943258735056394325873

GMDN Terms

TermDefinition
Body-powered elbow prosthesis, lockingAn artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of connecting straps/cables or other mechanism powered by the movement of body segments, or it moves as the result of a connection with another functional limb component. The position of the device can be maintained by a locking mechanism that is body- or externally-powered.

Sterilization Methods

Method

Regulatory Flags

DUNS number
210280350
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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