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Aesculap

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
AESCULAP FDA UDI
Generic Name
Orbital sphere implant introducer FDA UDI
Device Name
CARTER SPHERE INTRODUCER 125MM FDA UDI
Model / Reference
MA974R FDA UDI
Description
CARTER SPHERE INTRODUCER 125MM FDA UDI

Identifiers

Catalog Number
MA974R FDA UDI
Primary DI / UDI-DI
04046964686665 FDA UDI
FDA Product Code
HNP FDA UDI
GMDN Term
Orbital sphere implant introducer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

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

Category: Orbital sphere implant introducer

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

Similar devices

Also classified as Orbital sphere implant introducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI 70f21ca7-fbb7-4553-8210-21605124ed50 35 fields · synced May 30, 2026