← Back to catalogue

GT Metabolic Instrument Set

FDA UDI

Class I (US FDA UDI)

by GT Metabolic Solutions, Inc.

Identity

Trade Name
GT Metabolic Instrument Set FDA UDI
Generic Name
Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI
Model / Reference
IS-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00850054216144 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Gastrointestinal anastomosis coupler, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Gastrointestinal anastomosis coupler, non-bioabsorbable

GT Metabolic Instrument Set by GT Metabolic Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal anastomosis coupler, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
GT Metabolic Solutions, Inc.

Sources (1)

  • FDA UDI 82b125b6-ed61-4449-9613-c7daef6414d1 32 fields · synced Jun 9, 2026