Orbital Depressor

FDA UDI

Class I (US FDA UDI)

by Medetz Surgical Instruments

Identity

Trade Name: Orbital Depressor FDA UDI
Generic Name: Orbital depressor, reusable FDA UDI
Device Name: Schocket Double End Scleral Depressor OL 138mm(5 3/8") FDA UDI
Model / Reference: 11-4097 FDA UDI
Description: Schocket Double End Scleral Depressor OL 138mm(5 3/8") FDA UDI

Identifiers

Primary DI / UDI-DI: G2231140970 FDA UDI
FDA Product Code: HNX FDA UDI
GMDN Term: Orbital depressor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

Yes

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: Orbital depressor, reusable

Orbital Depressor by Medetz Surgical Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
V. Mueller — STERIS CORPORATION · Class I
Bausch + Lomb — Bausch & Lomb Incorporated · Class I
Schepens Scleral Depressor — SONTEC INSTRUMENTS, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · 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: Medetz Surgical Instruments

Sources (1)

FDA UDI 82f8d5a7-7f9f-4746-bfef-6ad6c326c4e9 34 fields · synced May 30, 2026