SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-IMF220

GUDID 07540194004383

FULL SLIM IMPLANT CASE Ø2.0MM

Pega Medical Inc

Arthrodesis nail, sterile

• Primary Device ID: 07540194004383
• NIH Device Record Key: 9fbd32cf-4a0b-454b-aa05-e7e781893753
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
• Version Model Number: SLM-IMF220
• Catalog Number: SLM-IMF220
• Company DUNS: 257315713
• Company Name: Pega Medical Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540194004383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143355

FDA Product Code

• HBS: INSTRUMENT, CLIP FORMING/CUTTING
• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

[07540194004383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-07

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

• 07540194004444: FULL SLIM IMPLANT CASE Ø6.4MM
• 07540194004437: FULL SLIM IMPLANT CASE Ø5.6MM
• 07540194004420: FULL SLIM IMPLANT CASE Ø4.8MM
• 07540194004413: FULL SLIM IMPLANT CASE Ø4.0MM
• 07540194004406: FULL SLIM IMPLANT CASE Ø3.2MM
• 07540194004390: FULL SLIM IMPLANT CASE Ø2.6MM
• 07540194004383: FULL SLIM IMPLANT CASE Ø2.0MM
• 07540194004246: SLIM Rod Cap Large M4.5 x 5.0mm
• 07540194004239: SLIM Rod Cap Small M4.5 x 1.5mm
• 07540194004222: SLIM Rod Cap Large M3.5 x 5.0mm
• 07540194004215: SLIM Rod Cap Small M3.5 x 1.5mm
• 07540194004208: SLIM Rod Ø6.4mm x 400mm
• 07540194004192: SLIM Rod Ø6.4mm x 380mm
• 07540194004185: SLIM Rod Ø6.4mm x 360mm
• 07540194004178: SLIM Rod Ø6.4mm x 340mm
• 07540194004161: SLIM Rod Ø6.4mm x 320mm
• 07540194004154: SLIM Rod Ø6.4mm x 300mm
• 07540194004147: SLIM Rod Ø6.4mm x 280mm
• 07540194004130: SLIM Rod Ø6.4mm x 260mm
• 07540194004123: SLIM Rod Ø6.4mm x 240mm
• 07540194004116: SLIM Rod Ø6.4mm x 220mm
• 07540194004109: SLIM Rod Ø6.4mm x 200mm
• 07540194004093: SLIM Rod Ø6.4mm x 190mm
• 07540194004086: SLIM Rod Ø6.4mm x 180mm
• 07540194004079: SLIM Rod Ø6.4mm x 170mm
• 07540194004062: SLIM Rod Ø6.4mm x 160mm
• 07540194004055: SLIM Rod Ø6.4mm x 150mm
• 07540194004048: SLIM Rod Ø6.4mm x 140mm
• 07540194004031: SLIM Rod Ø6.4mm x 130mm
• 07540194004024: SLIM Rod Ø6.4mm x 120mm
• 07540194004017: SLIM Rod Ø6.4mm x 110mm
• 07540194004000: SLIM Rod Ø6.4mm x 100mm
• 07540194003997: SLIM Rod Ø6.4mm x 90mm
• 07540194003980: SLIM Rod Ø6.4mm x 80mm
• 07540194003973: SLIM Rod Ø5.6mm x 400mm
• 07540194003966: SLIM Rod Ø5.6mm x 380mm
• 07540194003959: SLIM Rod Ø5.6mm x 360mm
• 07540194003942: SLIM Rod Ø5.6mm x 340mm
• 07540194003935: SLIM Rod Ø5.6mm x 320mm
• 07540194003928: SLIM Rod Ø5.6mm x 300mm
• 07540194003911: SLIM Rod Ø5.6mm x 280mm
• 07540194003904: SLIM Rod Ø5.6mm x 260mm
• 07540194003898: SLIM Rod Ø5.6mm x 240mm
• 07540194003881: SLIM Rod Ø5.6mm x 220mm
• 07540194003874: SLIM Rod Ø5.6mm x 200mm
• 07540194003867: SLIM Rod Ø5.6mm x 190mm
• 07540194003850: SLIM Rod Ø5.6mm x 180mm
• 07540194003843: SLIM Rod Ø5.6mm x 170mm
• 07540194003836: SLIM Rod Ø5.6mm x 160mm
• 07540194003829: SLIM Rod Ø5.6mm x 150mm