Long Trephine Drill +2 more models

FDA UDI

Class I (US FDA UDI)

by Biotechnology Institute Sl

Identity

Trade Name: LONG TREPHINE DRILL; INTERNAL Ø 5,1 MM; L: 8 MM FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Model / Reference: FTEXL51-8 FDA UDI

Identifiers

Catalog Number: FTEXL51-8 FDA UDI
Primary DI / UDI-DI: 08435389825142 FDA UDI
FDA Product Code: EJL FDA UDI
GMDN Term: Bone trephine, reusable FDA UDI
Models / Variants: Long Trephine Drill FDA UDI
Internal Ø 5, 1 Mm FDA UDI
L: 8 Mm FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3240 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone trephine, reusable

Long Trephine Drill +2 more models by Biotechnology Institute Sl — Class I — FDA UDI — listed in FDA GUDID — 3 models — 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: Biotechnology Institute Sl

Sources (1)

FDA UDI f019cc9d-8175-4fb0-b6a0-cdfde7cad964 33 fields · synced Jun 6, 2026