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GT Metabolic DI Magnet - 40mm

FDA UDI

Class II (US FDA UDI)

by GT Metabolic Solutions, Inc.

Identity

Trade Name
GT Metabolic DI Magnet - 40mm FDA UDI
Generic Name
Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI
Model / Reference
MAG-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00850054216069 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
MRI Safety
MR Unsafe FDA UDI

Category: Gastrointestinal anastomosis coupler, non-bioabsorbable

GT Metabolic DI Magnet - 40mm by GT Metabolic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal anastomosis coupler, non-bioabsorbable.

Cleared under the same submission

K242086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GT Metabolic Solutions, Inc.

Sources (1)

  • FDA UDI 2a1ea67d-4baa-4405-b66e-b388652336a7 33 fields · synced Jun 9, 2026