Simpulse

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name: Simpulse FDA UDI
Generic Name: Surgical mist irrigation tip FDA UDI
Device Name: Showerhead Tip FDA UDI
Model / Reference: 0057621 FDA UDI
Description: Showerhead Tip FDA UDI

Identifiers

Catalog Number: 0057621 FDA UDI
Primary DI / UDI-DI: 00801741010415 FDA UDI
FDA Product Code: FQH FDA UDI
GMDN Term: Surgical mist irrigation tip FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical mist irrigation tip

Simpulse by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical mist irrigation tip.

Premium Plus — Premium Plus International Limited · Class I
Premium Plus — Premium Plus International Limited · Class I
Premium Plus — Premium Plus International Limited · Class I
Premium Plus — Premium Plus International Limited · Class I
EndoWrist — Intuitive Surgical, Inc. · Class II
HI-LINE XS — AESCULAP, INC. · Class I
Juneland — Suzhou Juneland Medical Co., Ltd. · Class II
VISAO™ — MEDTRONIC XOMED, INC. · Class II

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 II	Pending data

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

Manufacturer

Manufacturer: Davol Inc.

Sources (1)

FDA UDI 1e8f0735-3d55-474e-a8e9-a77c4c1eafba 36 fields · synced May 31, 2026