Geminus XL GMN-XL-SYS

GUDID 00841506109961

GEMINUS XL Volar Distal Radius Plate System

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841506109961
• NIH Device Record Key: 88f1eda4-4c04-43ec-a40a-2126bc63c516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geminus XL
• Version Model Number: GEMINUS XL System
• Catalog Number: GMN-XL-SYS
• Company DUNS: 869056148
• Company Name: SKELETAL DYNAMICS L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506109961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182492

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [Geminus XL]

• 00841506109961: GEMINUS XL Volar Distal Radius Plate System
• 00841506109176: GEMINUS Volar Distal Plate System Long Plate Module
• 00841506109121: Tissue Protector/Drill Guide, Slot, 2.5mm
• 00841506107509: Assembled, Geminus Volar Distal Radius Plate, Narrow, 200mm, Left
• 00841506107493: Assembled, Geminus Volar Distal Radius Plate, Narrow, 200mm, Right
• 00841506107486: Assembled, Geminus Volar Distal Radius Plate, Narrow, 160mm, Left
• 00841506107479: Assembled, Geminus Volar Distal Radius Plate, Narrow, 160mm, Right
• 00841506107462: Assembled, Geminus Volar Distal Radius Plate, Narrow, 120mm, Left
• 00841506107455: Assembled, Geminus Volar Distal Radius Plate, Narrow, 120mm, Right
• 00841506107448: Geminus Volar Distal Radius Plate, Narrow, 200mm, Left
• 00841506107431: Geminus Volar Distal Radius Plate, Narrow, 200mm, Right
• 00841506107424: Geminus Volar Distal Radius Plate, Narrow, 165mm, Left
• 00841506107417: Geminus Volar Distal Radius Plate, Narrow, 165mm, Right
• 00841506107400: Geminus Volar Distal Radius Plate, Narrow, 125mm, Left
• 00841506107394: Geminus Volar Distal Radius Plate, Narrow, 125mm, Right
• 00841506107387: Geminus Volar Distal Radius Plate, Standard, 200mm, Left
• 00841506107370: Geminus Volar Distal Radius Plate, Standard, 200mm, Right
• 00841506107363: Geminus Volar Distal Radius Plate, Standard, 165mm, Left