FDA.report

Orthopediatrics Instrumentation

Primary DI
00841132173992
Brand
Orthopediatrics Instrumentation
Company
ORTHOPEDIATRICS CORP.
Model
01-1400-1070
Catalog number
01-1400-1070
Device description
4.0/2.0 Double Drill Guide
Published
2019-09-03
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
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841132173992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132173992008411321739928411321739920841132173992

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)268-6379bsmith@orthopediatric.com

Regulatory Flags

DUNS number
796416191
Device count
1
DM exempt
true
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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