FDA.report

PNP Femur

Primary DI
00840194472586
Brand
PNP Femur
Company
ORTHOPEDIATRICS CORP.
Model
01-1501-0090-S
Catalog number
01-1501-0090-S
Device description
10mm Opening Reamer
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
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194472586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194472586008401944725868401944725860840194472586

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer shaftA flexible cylindrical device intended to accept an orthopaedic reamer head on its distal end and used during a procedure to open and enlarge a medullary canal (e.g., in the femur), for the insertion of devices during prosthesis implantation or for fracture fixation. It is designed to be mounted onto an appropriate surgical tool for manual or powered rotation and is made of flexible materials (e.g., carbon fibre); it has a hollow centre so it can be fed over a guide, and devices to assist the procedure (e.g., drill guiding pin, manual driver) may be provided with the device. This is a single-use 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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