DIRECTguide™ Sleeve Narrow (5PK)

FDA UDI

Class I (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name: DIRECTguide™ Sleeve Narrow (5PK) FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Model / Reference: GSN-Lab FDA UDI

Identifiers

Catalog Number: GSN-Lab FDA UDI
Primary DI / UDI-DI: 10841307132134 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 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

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

DIRECTguide™ Sleeve Narrow (5PK) by Implant Direct Sybron Manufacturing Llc — 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: Implant Direct Sybron Manufacturing Llc

Sources (1)

FDA UDI 897117b3-39e2-4179-8434-991b3538c110 34 fields · synced May 31, 2026