SPLATTER-GARD Tip and Cap Set

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: SPLATTER-GARD Tip and Cap Set FDA UDI
Generic Name: Irrigation syringe FDA UDI
Device Name: SPLATTER-GARD Tip and Cap Set FOR USE WITH IRRIJET® OR IRRIJET® DS FDA UDI
Model / Reference: 55-6100 FDA UDI
Description: SPLATTER-GARD Tip and Cap Set FOR USE WITH IRRIJET® OR IRRIJET® DS FDA UDI

Identifiers

Primary DI / UDI-DI: 60888937015968 FDA UDI
FDA Product Code: KYZ FDA UDI
GMDN Term: Irrigation syringe FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6960 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Irrigation syringe

SPLATTER-GARD Tip and Cap Set by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: CooperSurgical, Inc.

Sources (1)

FDA UDI ec8e95b8-6832-437a-a3b0-6c3adba61783 33 fields · synced Jun 9, 2026