FDA.report

AGILON® XO Goniometer

Primary DI
04048844381226
Brand
AGILON® XO Goniometer
Company
implantcast GmbH
Model
78013000
Published
2022-09-06
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
KQWGoniometer, Nonpowered

Product Code Classifications

CodeDeviceSpecialtyClass
KQWGoniometer, NonpoweredOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048844381226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844381226040488443812264048844381226

GMDN Terms

TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
324369826
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04048844732028implaFit®800920062026-03-20
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