Identity
- Trade Name
- GT Metabolic Delivery System FDA UDI
- Generic Name
- Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI
- Model / Reference
- DS-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850054216052 FDA UDI
- 510(k) Number
- K242086 FDA UDI
- FDA Product Code
- SAH FDA UDI
- GMDN Term
- Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4816 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Gastrointestinal anastomosis coupler, non-bioabsorbable
GT Metabolic Delivery System by GT Metabolic Solutions, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal anastomosis coupler, non-bioabsorbable.
- GT Metabolic Laparoscopic Positioning Device — GT Metabolic Solutions, Inc. · Class I
- GT Metabolic Laparoscopic Positioning Device — GT Metabolic Solutions, Inc. · Class I
- GT Metabolic DI Magnet - 50mm — GT Metabolic Solutions, Inc. · Class II
- GT Metabolic Laparoscopic Positioning Device — GT Metabolic Solutions, Inc. · Class I
- GT Metabolic Instrument Set — GT Metabolic Solutions, Inc. · Class I
- GT Metabolic DI Magnet - 40mm — GT Metabolic Solutions, Inc. · Class II
- GT Metabolic Laparoscopic Positioning Device — GT Metabolic Solutions, Inc. · Class I
- GT Metabolic Laparoscopic Positioning Device — GT Metabolic Solutions, Inc. · Class I
Cleared under the same submission
K242086 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GT Metabolic Solutions, Inc.
Sources (2)
- FDA UDI cc77501a-d56c-4569-b586-59c2c610d315 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026