← Back to catalogue

Macro-Line

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
MACRO-LINE FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Device Name
MACRO-LINE HDPC F/INTRAMED.REAMERS (DIN) FDA UDI
Model / Reference
GB115R FDA UDI
Description
MACRO-LINE HDPC F/INTRAMED.REAMERS (DIN) FDA UDI

Identifiers

Catalog Number
GB115R FDA UDI
Primary DI / UDI-DI
04038653068821 FDA UDI
FDA Product Code
HBD 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
882.4325 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

Macro-Line 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI 38a13e09-78e2-4fc7-9730-658d35f69b8c 35 fields · synced May 30, 2026