Retrieval Pouch (Multi Deploy) 12mm OS-RP-12

GUDID B354OSRP1210

Retrieval Pouch (Multi Deploy) 12mm

ORANGE SURGICAL INSTRUMENTS, LLC

Tissue extraction bag

• Primary Device ID: B354OSRP1210
• NIH Device Record Key: c91b964a-5854-4dfa-bbb0-abefad70bb33
• Commercial Distribution Discontinuation: 2019-11-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Retrieval Pouch (Multi Deploy) 12mm
• Version Model Number: OS-RP-12
• Catalog Number: OS-RP-12
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	B354OSRP120 [Primary]
HIBCC	B354OSRP1210 [Package]; Contains: B354OSRP120; Package: [10 Units]; Discontinued: 2019-11-07; 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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-07
• Device Publish Date: 2016-11-07

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