Lap Port Closure Guides 5mm and 10/12mm Box of 10 Reusable

GUDID B34500

Lap Port Closure Guides 5mm and 10/12mm Box of 10 Reusable

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B34500
• NIH Device Record Key: d66b274b-2abc-4b39-b683-de92c7dd3eaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lap Port Closure Guides 5mm and 10/12mm Box of 10 Reusable
• Version Model Number: OSLPCDGR51012
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 99999
• 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	B34500 [Unit of Use]
HIBCC	B354OSLPCDGR510121 [Primary]
HIBCC	B354OSLPCDGR510122 [Primary]
HIBCC	B354OSLPCDGR510123 [Primary]
HIBCC	B354OSLPCDGR510124 [Primary]
HIBCC	B354OSLPCDGR510125 [Primary]
HIBCC	B354OSLPCDGR510129 [Primary]
HIBCC	B354OSLPCDK1 [Primary]
HIBCC	B354OSLPCDK2 [Primary]
HIBCC	B354OSLPCDK3 [Primary]
HIBCC	B354OSLPCDK4 [Primary]
HIBCC	B354OSLPCDK5 [Primary]
HIBCC	B354OSLPCDK9 [Primary]
HIBCC	OSLPCDGR510121 [Primary]
HIBCC	OSLPCDGR510122 [Primary]
HIBCC	OSLPCDGR510123 [Primary]
HIBCC	OSLPCDGR510124 [Primary]
HIBCC	OSLPCDGR510125 [Primary]
HIBCC	OSLPCDGR510129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [Lap Port Closure Guides 5mm and 10/12mm Box of 10 Reusable]

• B34500: Lap Port Closure Guides 5mm and 10/12mm Box of 10 Reusable
• OSLPCDGR510120: Lap Port Closure Guides 5mm and 10/12mm Box of 10 Reusable