InterLock Trocar 1001

GUDID 00856853006009

FUJIFILM NEW DEVELOPMENT U.S.A., INC.

Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use

• Primary Device ID: 00856853006009
• NIH Device Record Key: 66d2b957-0a74-4633-b3e1-84014a1b3ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterLock Trocar
• Version Model Number: Rev A
• Catalog Number: 1001
• Company DUNS: 005065629
• Company Name: FUJIFILM NEW DEVELOPMENT U.S.A., INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856853006009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170084

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: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-05-17

Devices Manufactured by FUJIFILM NEW DEVELOPMENT U.S.A., INC.

• 00856853006009 - InterLock Trocar: 2020-01-09
• 00856853006009 - InterLock Trocar: 2020-01-09
• 00856853006023 - Fujifilm Surgical System: 2019-02-21 Video Processor
• 00856853006030 - Fujifilm Surgical System: 2019-02-21 Light Source
• 00856853006047 - Fujifilm Surgical System: 2019-02-21
• 00856853006016 - Fujifilm Surgical System: 2018-11-08