Silhouette Sizers, 4 Pack

FDA UDI

Class I (US FDA UDI)

by Parker Hannifin Corp.

Identity

Trade Name: SILHOUETTE SIZERS,4 PACK FDA UDI
Generic Name: Anaesthesia face mask, reusable FDA UDI
Device Name: SILHOUETTE SIZERS,4 PACK FDA UDI
Model / Reference: SIL-SIZER-4 FDA UDI
Description: SILHOUETTE SIZERS,4 PACK FDA UDI

Identifiers

Catalog Number: SIL-SIZER-4 FDA UDI
Primary DI / UDI-DI: 00816711022008 FDA UDI
FDA Product Code: CAI FDA UDI
GMDN Term: Anaesthesia face mask, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5240 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Anaesthesia face mask, reusable

Silhouette Sizers, 4 Pack by Parker Hannifin Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AincA® — Anesthesia Associates, Inc. · Class I
Anesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5 — FLEXICARE MEDICAL LIMITED · Class I
AincA® — Anesthesia Associates, Inc. · Class I
O-Two — O-Two Medical Technologies Inc · Class I
AincA® — Anesthesia Associates, 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

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Manufacturer

Manufacturer: Parker Hannifin Corp.

Sources (1)

FDA UDI 3ae5d600-ae48-4b24-9eaf-aa1dab9243ac 34 fields · synced May 30, 2026