FDA.report

KONG VBR Instrument, Trial Implant, XL + ES, Ø 19 mm x 60 mm

Primary DI
07640172551349
Brand
KONG VBR Instrument, Trial Implant, XL + ES, Ø 19 mm x 60 mm
Company
icotec AG
Model
44-005-60
Device description
KONG VBR Instrument, Trial Implant, XL + ES, Ø 19 mm x 60 mm
Published
2020-06-19
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
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications

CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640172551349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640172551349076401725513497640172551349

GMDN Terms

TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+41717570000info@icotec.ch

Regulatory Flags

DUNS number
480789465
Device count
1
DM exempt
false
Premarket exempt
false
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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