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ROLAND DIRECTIONAL S/I, 5FR. x 10CM

FDA UDI

Class I (US FDA UDI)

by Grace Medical, Inc.

Identity

Trade Name
ROLAND DIRECTIONAL S/I, 5FR. x 10CM FDA UDI
Generic Name
Surgical irrigation/aspiration handpiece, reusable FDA UDI
Device Name
ROLAND DIRECTIONAL SUCTION IRRIGATOR, 5FR. x 10CM, STAINLESS STEEL FDA UDI
Model / Reference
991-TR5-10 FDA UDI
Description
ROLAND DIRECTIONAL SUCTION IRRIGATOR, 5FR. x 10CM, STAINLESS STEEL FDA UDI

Identifiers

Primary DI / UDI-DI
00844505011303 FDA UDI
FDA Product Code
JZF FDA UDI
GMDN Term
Surgical irrigation/aspiration handpiece, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: Surgical irrigation/aspiration handpiece, reusable

ROLAND DIRECTIONAL S/I, 5FR. x 10CM by Grace Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration handpiece, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Grace Medical, Inc.

Sources (1)

  • FDA UDI 74d1728f-b93d-47e0-ad1c-fe32e6b33acb 34 fields · synced Jun 6, 2026