Standard Precision Bougie Device

FDA UDI

Class II (US FDA UDI)

by Standard Bariatrics

Identity

Trade Name: Standard Precision Bougie Device FDA UDI
Generic Name: Gastric calibration tube FDA UDI
Device Name: Standard Precision Bougie Device Non-Sterile 38Fr FDA UDI
Model / Reference: STB38 FDA UDI
Description: Standard Precision Bougie Device Non-Sterile 38Fr FDA UDI

Identifiers

Catalog Number: STB38 FDA UDI
Primary DI / UDI-DI: 00851677007171 FDA UDI
510(k) Number: K222085 FDA UDI
FDA Product Code: KNT FDA UDI
GMDN Term: Gastric calibration tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastric calibration tube

Standard Precision Bougie Device by Standard Bariatrics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Gastric calibration tube.

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Gastric Balloon Suction Catheter — ReShape Lifesciences Inc. · Class II
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Cleared under the same submission

K222085 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Standard Bariatrics

Sources (1)

FDA UDI b5b2ebac-f924-4abc-bf60-3f5a41194e00 35 fields · synced May 31, 2026