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Hintermann Series

FDA UDI

Class I (US FDA UDI)

by Dt Medtech, LLC

Identity

Trade Name
Hintermann Series FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Drilling Guide ø 2.7 and 2.0 Instrument FDA UDI
Model / Reference
1 FDA UDI
Description
Drilling Guide ø 2.7 and 2.0 Instrument FDA UDI

Identifiers

Catalog Number
159127 FDA UDI
Primary DI / UDI-DI
B095159127 FDA UDI
510(k) Number
K171004 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

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

Hintermann Series by Dt Medtech, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K171004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dt Medtech, LLC

Sources (1)

  • FDA UDI 5e213def-d1bc-45a5-87e6-2dcda2b5ab4a 37 fields · synced Jun 6, 2026