12100

GUDID 03700393300257

Single use, sharp trocar for laparoscopic surgery

PETERS SURGICAL

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

• Primary Device ID: 03700393300257
• NIH Device Record Key: 1aa406e6-af02-4278-94df-17014b0ff28f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 12100
• Catalog Number: 12100
• Company DUNS: 265741780
• Company Name: PETERS SURGICAL
• 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

Customer Support Contacts

• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com
• Phone: +1 508-747-6033
• Email: e.knupp@peters-surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700393300257 [Package]; Contains: 03700393300264; Package: Box [25 Units]; In Commercial Distribution
GS1	03700393300264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071976

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-12

Devices Manufactured by PETERS SURGICAL

• 03661522100882 - Applier, hemostatic clip: 2024-01-10
• 03661522100899 - Applier, hemostatic clip: 2024-01-10
• 03661522100905 - Applier, hemostatic clip: 2024-01-10
• 03661522100929 - Applier, hemostatic clip: 2024-01-10
• 03661522100936 - Applier, hemostatic clip: 2024-01-10
• 03661522100912 - Applier, hemostatic clip: 2024-01-05
• 03661522000984 - Sertilac: 2023-06-19
• 03661522039540 - Applier, hemostatic clip: 2023-06-16