GT Metabolic Delivery System

GUDID 00850054216052

Gt Metabolic Solutions, Inc.

Gastrointestinal anastomosis coupler, non-bioabsorbable
Primary Device ID00850054216052
NIH Device Record Keycc77501a-d56c-4569-b586-59c2c610d315
Commercial Distribution StatusIn Commercial Distribution
Brand NameGT Metabolic Delivery System
Version Model NumberDS-01
Company DUNS108055496
Company NameGt Metabolic Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850054216052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SAHMagnetic Compression Anastomosis System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-23
Device Publish Date2024-12-13

Devices Manufactured by Gt Metabolic Solutions, Inc.

00850054216007 - GT Metabolic Laparoscopic Positioning Device2024-12-23
00850054216014 - GT Metabolic Laparoscopic Positioning Device2024-12-23
00850054216021 - GT Metabolic Laparoscopic Positioning Device2024-12-23
00850054216038 - GT Metabolic Laparoscopic Positioning Device2024-12-23
00850054216045 - GT Metabolic Laparoscopic Positioning Device2024-12-23
00850054216052 - GT Metabolic Delivery System2024-12-23
00850054216052 - GT Metabolic Delivery System2024-12-23
00850054216069 - GT Metabolic DI Magnet - 40mm2024-12-23
00850054216144 - GT Metabolic Instrument Set2024-12-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.