Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Nasal speculum, reusable FDA UDI
Device Name: COTTLE NASAL SPECULA 85MM 5.75 FDA UDI
Model / Reference: 41-1197 FDA UDI
Description: COTTLE NASAL SPECULA 85MM 5.75 FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111219825 FDA UDI
FDA Product Code: EPY FDA UDI
GMDN Term: Nasal speculum, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Nasal speculum, reusable

A comprehensive medical device directory listing the Sklar COTTLE NASAL SPECULA 85MM 5.75, a hand-held surgical instrument used for general ENT (Ear, Nose, Throat) surgery.

Similar devices

Also classified as Nasal speculum, reusable.

Cottle septum speculum — Spiggle & Theis Medizintechnik GmbH · Class I
Integra® — Integra LifeSciences Production Corporation · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
FENTEX — FENTEX medical GmbH · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Papavero Speculum, Titanium, 90x13mm Jaw — MIZUHO AMERICA, INC. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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

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

Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI f531f9ac-cb6d-4d37-80f1-962119a4fbab 33 fields · synced Jul 17, 2026