RLZPT2

GUDID 30705036004015

Gastric Band Sutureless Port and Applier

Obtech Medical Sàrl

Gastric band access port kit

• Primary Device ID: 30705036004015
• NIH Device Record Key: f11c5867-46d2-4010-871c-a6b451332756
• Commercial Distribution Discontinuation: 2020-04-13
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: RLZPT2
• Catalog Number: RLZPT2
• Company DUNS: 486911852
• Company Name: Obtech Medical Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705036004018 [Primary]
GS1	30705036004015 [Package]; Contains: 20705036004018; Package: CASE [16 Units]; Discontinued: 2020-04-13; Not in Commercial Distribution

FDA Product Code

• LTI: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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: 2020-04-14
• Device Publish Date: 2014-09-17

Devices Manufactured by Obtech Medical Sàrl

• 30705036003964 - N/A: 2020-04-14 Gastric Band Dissector
• 30705036003971 - N/A: 2020-04-14 Gastric Calibration Tube
• 30705036003988 - N/A: 2020-04-14 Gastric Calibration Tube
• 30705036004015 - NA: 2020-04-14Gastric Band Sutureless Port and Applier
• 30705036004015 - NA: 2020-04-14 Gastric Band Sutureless Port and Applier
• 30705036004008 - NA: 2019-11-07 Curved Adjustable Gastric Band with Sutureless Port and Applier
• 20705036011665 - NA: 2018-03-29 GASTRIC BAND KIT
• 20705036011672 - NA: 2018-03-29 GASTRIC BAND KIT
• 20705036011689 - NA: 2018-03-29 GASTRIC BAND KIT