FDA.report

Orthex/ Instrument Case

Primary DI
00841132178706
Brand
Orthex/ Instrument Case
Company
ORTHOPEDIATRICS CORP.
Model
01-2200-0102
Catalog number
01-2200-0102
Device description
Rail Tray - Lid
Published
2020-11-04
Public version status
Update
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841132178706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132178706008411321787068411321787060841132178706

GMDN Terms

TermDefinition
External orthopaedic fixation frame calculation softwareA stand-alone software application designed provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be installed on an off-the-shelf computer/smart device as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(574)268-6379jdugger@orthopediatrics.com

Regulatory Flags

DUNS number
796416191
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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