GT Metabolic Laparoscopic Positioning Device
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- GT Metabolic Laparoscopic Positioning Device, 21 EUDAMEDGT Metabolic Laparoscopic Positioning Device FDA UDI
- Generic Name
- Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI
- Device Name
- GT Metabolic Laparoscopic Positioning Device EUDAMED
- Model / Reference
- PD-21 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850054216021 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850054216PD8U EUDAMED
- Direct Marketing DI
- 00850054216021 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L1299 LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Gastrointestinal anastomosis coupler, non-bioabsorbable
GT Metabolic Laparoscopic Positioning Device by GT Metabolic Solutions, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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 Delivery System — GT Metabolic Solutions, Inc. · Class II
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GT Metabolic Solutions, Inc.
Sources (2)
- FDA UDI 1888395c-66c5-430a-9d71-c303e3138595 32 fields · synced Aug 3, 2026
- EUDAMED 431c0a71-e4f6-423b-b83d-773e41841ca1 61 fields · synced Aug 3, 2026