TwinLoop

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: TwinLoop FDA UDI
Generic Name: Surgical drill guide obturator FDA UDI
Device Name: OBTURATOR, 3.5MM TWIN LOOP FDA UDI
Model / Reference: 3910-400-003 FDA UDI
Description: OBTURATOR, 3.5MM TWIN LOOP FDA UDI

Identifiers

Catalog Number: 3910-400-003 FDA UDI
Primary DI / UDI-DI: 04546540678188 FDA UDI
FDA Product Code: NBH FDA UDI
GMDN Term: Surgical drill guide obturator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical drill guide obturator

TwinLoop by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI 65697a29-ec30-4593-b95e-809f120d2869 36 fields · synced Jun 6, 2026