Aesculap

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: AESCULAP FDA UDI
Generic Name: Dental spatula, reusable FDA UDI
Device Name: HEIDEMANN Dental Spatula, 7", (175 mm), double ended, elastic, especially flexible, ergonomic handle, peek handle, width: 3 mm, green, non-sterile, reusable FDA UDI
Model / Reference: DE158R FDA UDI
Description: HEIDEMANN Dental Spatula, 7", (175 mm), double ended, elastic, especially flexible, ergonomic handle, peek handle, width: 3 mm, green, non-sterile, reusable FDA UDI

Identifiers

Catalog Number: DE158R FDA UDI
Primary DI / UDI-DI: 04038653242818 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Dental spatula, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental spatula, reusable

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

Similar devices

Also classified as Dental spatula, reusable.

Power Dental USA — Power Dental USA, Inc. · Class I
Plasdent — PLASDENT CORP. · Class I
CERVICAL MATRIX — TDV DENTAL LTDA · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
Quinelato — Schobell Industrial Ltda · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
Power Dental USA — Power Dental USA, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Aesculap, Inc.

Sources (1)

FDA UDI a0344cc6-10cb-45d5-abd0-c7f219bac3f1 35 fields · synced May 30, 2026