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Noir

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
NOIR FDA UDI
Generic Name
Open-surgery dissector FDA UDI
Device Name
NOIR Micro Curette, 90 °, angled, 7 7/8", (200 mm), diam. 4 mm, with long neck, black, non-sterile, reusable FDA UDI
Model / Reference
FD828B FDA UDI
Description
NOIR Micro Curette, 90 °, angled, 7 7/8", (200 mm), diam. 4 mm, with long neck, black, non-sterile, reusable FDA UDI

Identifiers

Catalog Number
FD828B FDA UDI
Primary DI / UDI-DI
04046964227608 FDA UDI
FDA Product Code
GZX FDA UDI
GMDN Term
Open-surgery dissector FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4525 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: Open-surgery dissector

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

Similar devices

Also classified as Open-surgery dissector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI 5c00a1c6-4a81-4fc5-9730-8f1d78132d6c 35 fields · synced May 30, 2026