Proximal Ulna Plate DRLL-35070R

GUDID 00841506115719

SKELETAL DYNAMICS L.L.C.

Fluted surgical drill bit, reusable

• Primary Device ID: 00841506115719
• NIH Device Record Key: 04f19fdb-5fa9-4f6b-8687-97a244597b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Ulna Plate
• Version Model Number: Drill, 3.5mm x 70mm, Reusable
• Catalog Number: DRLL-35070R
• 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
• 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	00841506115719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231623

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

[00841506115719]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [Proximal Ulna Plate]

• 00841506134918: PUP Extension, 2 Hole
• 00841506134901: PUP Extension, 1 Hole
• 00841506134437: FreeFix, Proximal Ulna Plate, 6 Slot, Left
• 00841506134420: FreeFix, Proximal Ulna Plate, 6 Slot, Right
• 00841506134413: FreeFix, Proximal Ulna Plate, 5 Slot Plus, Left
• 00841506134406: FreeFix, Proximal Ulna Plate, 5 Slot Plus, Right
• 00841506134390: FreeFix, Proximal Ulna Plate, 5 Slot, Left
• 00841506134383: FreeFix, Proximal Ulna Plate, 5 Slot, Right
• 00841506134376: FreeFix, Proximal Ulna Plate, 4 Slot, Left
• 00841506134369: FreeFix, Proximal Ulna Plate, 4 Slot, Right
• 00841506134352: FreeFix, Proximal Ulna Plate, 3 Slot, Left
• 00841506134345: FreeFix, Proximal Ulna Plate, 3 Slot, Right
• 00841506134321: FreeFix, Proximal Ulna Plate, 2 Slot, Right
• 00841506134215: Drill Guide, FreeFix™, PUP
• 00841506131917: Proximal Ulna Plating System, Sterilization Tray,
• 00841506131900: Proximal Ulna Plating System, Sterilization Tray,
• 00841506131894: Proximal Ulna Plating System, Sterilization Tray,
• 00841506131887: Proximal Ulna Plating System, Sterilization Tray,
• 00841506131870: Proximal Ulna Plating System, Sterilization Tray,
• 00841506131689: Proximal Ulna Plating System, Sterilization Tray (
• 00841506130224: Screw, FreeFix™ Compression, 3.5mm x 08mm, Ti
• 00841506129990: Screw, FreeFix Locking, 3.5mm x 08mm, Ti
• 00841506115719: Drill, 3.5mm x 70mm, Reusable
• 00841506134338: FreeFix, Proximal Ulna Plate, 2 Slot, Left
• 00841506131986: Proximal Ulna Plating System