Assi

FDA UDI

Class I (US FDA UDI)

by Accurate Surgical & Scientific Instruments Corp.

Identity

Trade Name: ASSI FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: O-Rings Replacement Part Set (2 Large 1 Small) fits 10mm Scope Sheath Support 3 per set FDA UDI
Model / Reference: ASSI.ABR1432R FDA UDI
Description: O-Rings Replacement Part Set (2 Large 1 Small) fits 10mm Scope Sheath Support 3 per set FDA UDI

Identifiers

Primary DI / UDI-DI: 00841645123200 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Endoscope sheath, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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: Endoscope sheath, reusable

Assi by Accurate Surgical & Scientific Instruments Corp. — 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: Accurate Surgical & Scientific Instruments Corp.

Sources (1)

FDA UDI 813278f2-de5d-43c1-ad01-c1d07b2b45f2 33 fields · synced Jun 8, 2026