Dr.Paleys Osteotomy System DRPFO-106

GUDID 07540194012852

Dr PALEY OUTRIGGER TIGHTENING SCREW

Pega Medical Inc

Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device Orthopaedic implant/instrument assembling device
Primary Device ID07540194012852
NIH Device Record Key02fb6e8b-0048-43d1-a022-6263c5bfb286
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr.Paleys Osteotomy System
Version Model NumberDRPFO-106
Catalog NumberDRPFO-106
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194012852 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


[07540194012852]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-22
Device Publish Date2021-04-14

On-Brand Devices [Dr.Paleys Osteotomy System]

07540194010681Dr PALEY RIGHT ANGLE CLAMP
07540194010674Dr PALEY PERIOSTEAL ELEVATOR
07540194010667Dr PALEY OSTEOTOME LEVER
07540194010650Dr PALEY OSTEOTOME 10 mm
07540194010643Dr PALEY OSTEOTOME 8 mm
07540194010636Dr PALEY OSTEOTOME 6 mm WITH GUIDE
07540194010629Dr PALEY OSTEOTOME 4 mm
07540194010612PALM HANDLE FOR ASSEMBLY (G-030101_CC)
07540194010605Dr PALEY GIGLI PASSER TUBE
07540194010599Dr PALEY GIGLI PASSER CURVED
07540194010582Dr PALEY GIGLI PASSER TUBE
07540194010575Dr PALEY GIGLI PASSER STRAIGHT
07540194010568Dr PALEY FEMORAL OUTRIGGER
07540194010551Dr PALEY FASCIOTOME
07540194010544Dr PALEY DRILL GUIDE
07540194010537Dr PALEY CORA PIN
07540194010520Dr PALEY DRILL Ø4.8mm
07540194010513Dr PALEY CURVED CLAMP
07540194010506Dr PALEY BEAM COMPASS
07540194010490Dr PALEY AUXILIARY PIN
07540194010483FULL Dr PALEY INSTRUMENT CASE
07540194010476Dr PALEY INSTRUMENT CASE RENTAL
07540194010469EMPTY Dr PALEY INSTRUMENT CASE
07540194012869Dr PALEY OUTRIGGER CLAMP
07540194012852Dr PALEY OUTRIGGER TIGHTENING SCREW
07540194012845Dr PALEY OUTRIGGER SPACER TUBE
07540194012838Dr PALEY OUTRIGGER PIN LINK
07540194012821Dr PALEY OUTRIGGER CORA PIN
07540194015815FULL DR PALEY INSTRUMENT CASE - 2ND GEN
07540194015075EMPTY DR PALEY INSTRUMENT CASE - 2ND GEN

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