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: Sheath w/1 rotating stop cock 17.5cm 5mm dia, w/non-glare satin finish FDA UDI
Model / Reference: ASSI.SU374526 FDA UDI
Description: Sheath w/1 rotating stop cock 17.5cm 5mm dia, w/non-glare satin finish FDA UDI

Identifiers

Primary DI / UDI-DI: 00841645135630 FDA UDI
FDA Product Code: FBM FDA UDI
GMDN Term: Endoscope sheath, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5090 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

Similar devices

Also classified as Endoscope sheath, reusable.

Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
SpineTIP — Karl Storz GmbH & Co. KG · Class II
Surgical Direct — SURGICAL DIRECT, 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 I	Pending data

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

Manufacturer

Manufacturer: Accurate Surgical & Scientific Instruments Corp.

Sources (1)

FDA UDI fa825e89-e083-40fe-b0ff-230ee86f235b 33 fields · synced Jun 1, 2026