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Acculan 3ti

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
ACCULAN 3TI FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Device Name
Acculan 3Ti K-wire attachment FDA UDI
Model / Reference
GB643R FDA UDI
Description
Acculan 3Ti K-wire attachment FDA UDI

Identifiers

Catalog Number
GB643R FDA UDI
Primary DI / UDI-DI
04038653460687 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Acculan 3ti by Aesculap, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI 7aa151c8-3814-44da-8ee1-c5314bfa18cf 35 fields · synced May 30, 2026