Versalock Upper Limb Plating System 343-10-08PE

GUDID 07899258664101

Versalock Superior Medial Small Left Clavicle Plate 08 Holes 3.5mm

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07899258664101
• NIH Device Record Key: df603d72-5579-4aee-968d-7e1f4ac69d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versalock Upper Limb Plating System
• Version Model Number: Versalock Superior Medial Small Left Clavicle Plat
• Catalog Number: 343-10-08PE
• Company DUNS: 900865213
• Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899258664101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243740

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

[07899258664101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-11
• Device Publish Date: 2025-02-03

On-Brand Devices [Versalock Upper Limb Plating System]

• 07899258664194: Versalock Superior Medial Right Clavicle Plate 12 Holes 3.5mm
• 07899258664187: Versalock Superior Medial Left Clavicle Plate 12 Holes 3.5mm
• 07899258664170: Versalock Superior Medial Right Clavicle Plate 10 Holes 3.5mm
• 07899258664163: Versalock Superior Medial Left Clavicle Plate 10 Holes 3.5mm
• 07899258664156: Versalock Superior Medial Large Right Clavicle Plate 08 Holes 3.5mm
• 07899258664149: Versalock Superior Medial Large Left Clavicle Plate 08 Holes 3.5mm
• 07899258664132: Versalock Superior Medial Medium Right Clavicle Plate 08 Holes 3.5mm
• 07899258664125: Versalock Superior Medial Medium Left Clavicle Plate 08 Holes 3.5mm
• 07899258664118: Versalock Superior Medial Small Right Clavicle Plate 08 Holes 3.5mm
• 07899258664101: Versalock Superior Medial Small Left Clavicle Plate 08 Holes 3.5mm
• 07899258664095: Versalock Superior Medial Right Clavicle Plate 06 Holes 3.5mm
• 07899258664088: Versalock Superior Medial Left Clavicle Plate 06 Holes 3.5mm
• 07899258664071: Versalock Superior Medial Right Clavicle Plate 04 Holes 3.5mm
• 07899258664064: Versalock Superior Medial Left Clavicle Plate 04 Holes 3.5mm