Lap-port closure device OS-LPCD

GUDID B354OSLPCD10

Lap-port closure device

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread

• Primary Device ID: B354OSLPCD10
• NIH Device Record Key: 926e2708-0489-4b03-a34a-510f7de88e3a
• Commercial Distribution Discontinuation: 2019-11-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Lap-port closure device
• Version Model Number: OS-LPCD
• Catalog Number: OS-LPCD
• 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	B354OSLPCD0 [Primary]
HIBCC	B354OSLPCD10 [Package]; Contains: B354OSLPCD0; Package: [10 Units]; Discontinued: 2019-11-15; 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: 2019-11-15
• Device Publish Date: 2016-11-15

Devices Manufactured by ORANGE SURGICAL INSTRUMENTS, LLC

• B354OS335MGTI0 - Grasper Traumatic Shaft insert 33 cm Disposable: 2025-02-18
• B354OS335MGTR0 - Grasper Traumatic with ratchet 33cm Disposable: 2025-02-18
• B354OS445RTG0 - Rat Tooth Grasper, 44cm, Disposable: 2025-02-18
• B354OS445RTGR0 - Rat Tooth Grasper w/Ratchet, 44cm, Disposable: 2025-02-18
• B354OSMCR4MMX5MR0 - 4mm Plug x 5M Monopolar Cable Reusable: 2025-02-18
• B354HAF2LGS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Small: 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Small Heart Assist, Single Use, 2 Finger Long, Malleable, 63mm W x 90mm L
• B354HAF2SHS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Large: 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Large Heart Assist, Sing Use, 2 Finger Short, Malleable 36mm x 54mm
• B354HAF3LGS0 - Stainless Steel Cardiac 3 Finger Heart Retractor - Small: 2025-01-17 Stainless Steel Cardiac 3 Finger Heart Retractor - Small Heart Assist, Single Use, 3 Finger Long, Malleable, 60mm W x 90mm