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Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
INSTRUMENT FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
SPECIALTY DRILL STRAIGHT SHAFT FDA UDI
Model / Reference
I-H10043325 FDA UDI
Description
SPECIALTY DRILL STRAIGHT SHAFT FDA UDI

Identifiers

Catalog Number
I-H10043325 FDA UDI
Primary DI / UDI-DI
07613327319743 FDA UDI
FDA Product Code
MEH FDA UDI
LPH FDA UDI
MBL FDA UDI
LWJ FDA UDI
KWL FDA UDI
JDI FDA UDI
KWY FDA UDI
HWC FDA UDI
MAY FDA UDI
KWZ FDA UDI
LZO FDA UDI
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
888.3350 FDA UDI
888.3390 FDA UDI
888.3040 FDA UDI
888.3310 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

Yes

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

Dimensions & Sizes

Size
Length — 25.0 Millimeter FDA UDI

Instrument by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 40a6c594-c50d-4b9b-a512-52df4b1e1d0e 36 fields · synced May 31, 2026