FDA.report

PNP Femur

Primary DI
00840194472388
Brand
PNP Femur
Company
ORTHOPEDIATRICS CORP.
Model
01-1503-0078-S
Catalog number
01-1503-0078-S
Device description
PNP Adolescent Conical Cannulated Extractor - Slap Hammer
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
FZYHAMMER, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194472388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194472388008401944723888401944723880840194472388

GMDN Terms

TermDefinition
Orthopaedic inorganic implant inserter/extractor, single-useA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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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00840194498944Response 5.5/6.001-1300-607301-1300-60732026-01-15
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