SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CAP-315

GUDID 07540194004215

SLIM Rod Cap Small M3.5 x 1.5mm

Pega Medical Inc

Arthrodesis nail, sterile
Primary Device ID07540194004215
NIH Device Record Keydee4dbec-a5b2-4fb0-94a5-23e56363180f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
Version Model NumberSLM-CAP-315
Catalog NumberSLM-CAP-315
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
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

Device Dimensions

Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter
Height1.5 Millimeter
Outer Diameter3.5 Millimeter

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
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
GS107540194004215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBSINSTRUMENT, CLIP FORMING/CUTTING
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

[07540194004215]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-20

On-Brand Devices [SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM]

07540194004444FULL SLIM IMPLANT CASE Ø6.4MM
07540194004437FULL SLIM IMPLANT CASE Ø5.6MM
07540194004420FULL SLIM IMPLANT CASE Ø4.8MM
07540194004413FULL SLIM IMPLANT CASE Ø4.0MM
07540194004406FULL SLIM IMPLANT CASE Ø3.2MM
07540194004390FULL SLIM IMPLANT CASE Ø2.6MM
07540194004383FULL SLIM IMPLANT CASE Ø2.0MM
07540194004246SLIM Rod Cap Large M4.5 x 5.0mm
07540194004239SLIM Rod Cap Small M4.5 x 1.5mm
07540194004222SLIM Rod Cap Large M3.5 x 5.0mm
07540194004215SLIM Rod Cap Small M3.5 x 1.5mm
07540194004208SLIM Rod Ø6.4mm x 400mm
07540194004192SLIM Rod Ø6.4mm x 380mm
07540194004185SLIM Rod Ø6.4mm x 360mm
07540194004178SLIM Rod Ø6.4mm x 340mm
07540194004161SLIM Rod Ø6.4mm x 320mm
07540194004154SLIM Rod Ø6.4mm x 300mm
07540194004147SLIM Rod Ø6.4mm x 280mm
07540194004130SLIM Rod Ø6.4mm x 260mm
07540194004123SLIM Rod Ø6.4mm x 240mm
07540194004116SLIM Rod Ø6.4mm x 220mm
07540194004109SLIM Rod Ø6.4mm x 200mm
07540194004093SLIM Rod Ø6.4mm x 190mm
07540194004086SLIM Rod Ø6.4mm x 180mm
07540194004079SLIM Rod Ø6.4mm x 170mm
07540194004062SLIM Rod Ø6.4mm x 160mm
07540194004055SLIM Rod Ø6.4mm x 150mm
07540194004048SLIM Rod Ø6.4mm x 140mm
07540194004031SLIM Rod Ø6.4mm x 130mm
07540194004024SLIM Rod Ø6.4mm x 120mm
07540194004017SLIM Rod Ø6.4mm x 110mm
07540194004000SLIM Rod Ø6.4mm x 100mm
07540194003997SLIM Rod Ø6.4mm x 90mm
07540194003980SLIM Rod Ø6.4mm x 80mm
07540194003973SLIM Rod Ø5.6mm x 400mm
07540194003966SLIM Rod Ø5.6mm x 380mm
07540194003959SLIM Rod Ø5.6mm x 360mm
07540194003942SLIM Rod Ø5.6mm x 340mm
07540194003935SLIM Rod Ø5.6mm x 320mm
07540194003928SLIM Rod Ø5.6mm x 300mm
07540194003911SLIM Rod Ø5.6mm x 280mm
07540194003904SLIM Rod Ø5.6mm x 260mm
07540194003898SLIM Rod Ø5.6mm x 240mm
07540194003881SLIM Rod Ø5.6mm x 220mm
07540194003874SLIM Rod Ø5.6mm x 200mm
07540194003867SLIM Rod Ø5.6mm x 190mm
07540194003850SLIM Rod Ø5.6mm x 180mm
07540194003843SLIM Rod Ø5.6mm x 170mm
07540194003836SLIM Rod Ø5.6mm x 160mm
07540194003829SLIM Rod Ø5.6mm x 150mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.