FDA.report

PNP Femur

Primary DI
00840194472340
Brand
PNP Femur
Company
ORTHOPEDIATRICS CORP.
Model
01-1501-0128-S
Catalog number
01-1501-0128-S
Device description
Child Nail Conical Extraction Adaptor
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWBEXTRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194472340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194472340008401944723408401944723400840194472340

GMDN Terms

TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(574)268-6379xxx@xxx.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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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