GT Metabolic Instrument Set

GUDID 00850054216144

Gt Metabolic Solutions, Inc.

Gastrointestinal anastomosis coupler, non-bioabsorbable

• Primary Device ID: 00850054216144
• NIH Device Record Key: 82b125b6-ed61-4449-9613-c7daef6414d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GT Metabolic Instrument Set
• Version Model Number: IS-01
• Company DUNS: 108055496
• Company Name: Gt Metabolic Solutions, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850054216144 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[00850054216144]

Moist Heat or Steam Sterilization

[00850054216144]

Moist Heat or Steam Sterilization

[00850054216144]

Moist Heat or Steam Sterilization

[00850054216144]

Moist Heat or Steam Sterilization

[00850054216144]

Moist Heat or Steam Sterilization

[00850054216144]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-13

Devices Manufactured by Gt Metabolic Solutions, Inc.

• 00850054216007 - GT Metabolic Laparoscopic Positioning Device: 2024-12-23
• 00850054216014 - GT Metabolic Laparoscopic Positioning Device: 2024-12-23
• 00850054216021 - GT Metabolic Laparoscopic Positioning Device: 2024-12-23
• 00850054216038 - GT Metabolic Laparoscopic Positioning Device: 2024-12-23
• 00850054216045 - GT Metabolic Laparoscopic Positioning Device: 2024-12-23
• 00850054216052 - GT Metabolic Delivery System: 2024-12-23
• 00850054216069 - GT Metabolic DI Magnet - 40mm: 2024-12-23
• 00850054216144 - GT Metabolic Instrument Set: 2024-12-23
• 00850054216144 - GT Metabolic Instrument Set: 2024-12-23