ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM 314-15-14D

GUDID 07899258656007

ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07899258656007
• NIH Device Record Key: 15782d8e-d7cb-46e6-a761-a21ae4d339e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM
• Version Model Number: ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PL
• Catalog Number: 314-15-14D
• 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	07899258656007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242998

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

[07899258656007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by GM DOS REIS INDUSTRIA E COMERCIO LTDA

• 07899258664064 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Left Clavicle Plate 04 Holes 3.5mm
• 07899258664071 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Right Clavicle Plate 04 Holes 3.5mm
• 07899258664088 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Left Clavicle Plate 06 Holes 3.5mm
• 07899258664095 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Right Clavicle Plate 06 Holes 3.5mm
• 07899258664101 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Small Left Clavicle Plate 08 Holes 3.5mm
• 07899258664118 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Small Right Clavicle Plate 08 Holes 3.5mm
• 07899258664125 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Medium Left Clavicle Plate 08 Holes 3.5mm
• 07899258664132 - Versalock Upper Limb Plating System: 2025-02-11 Versalock Superior Medial Medium Right Clavicle Plate 08 Holes 3.5mm