FDA.report

T15 Drivers

Primary DI
00840194422451
Brand
T15 Drivers
Company
ORTHOPEDIATRICS CORP.
Model
01-9000-0117
Catalog number
01-9000-0117
Device description
T15 Non-Retaining Removal Driver, Long
Published
2022-10-21
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
HXXSCREWDRIVER

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194422451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194422451008401944224518401944224510840194422451

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(574)268-6379yli@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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00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
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