Reusable Ratchet Handle - Tips 42cm OS-4-R

GUDID B354OS4R10

Reusable Ratchet Handle - Tips 42cm

ORANGE SURGICAL INSTRUMENTS, LLC

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• Primary Device ID: B354OS4R10
• NIH Device Record Key: 2651796a-f583-477b-ab9c-69b277b3a382
• Commercial Distribution Discontinuation: 2019-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Reusable Ratchet Handle - Tips 42cm
• Version Model Number: OS-4-R
• Catalog Number: OS-4-R
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B354OS4R0 [Primary]
HIBCC	B354OS4R10 [Package]; Contains: B354OS4R0; Package: [10 Units]; Discontinued: 2019-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

[B354OS4R10]

Peracetic Acid

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-14
• Device Publish Date: 2016-11-14

On-Brand Devices [Reusable Ratchet Handle - Tips 42cm]

• B354OS4R10: Reusable Ratchet Handle - Tips 42cm
• B35441: Reusable Ratchet Handle - Tips 42cm