Key Surgical Mr. Clear Anti-Fog AF-031

GUDID 10849771037856

Key Surgical Mr. Clear Anti-Fog is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.

KEY SURGICAL, INC.

Endoscopic antifog solution
Primary Device ID10849771037856
NIH Device Record Keyc3589d7b-2c0a-4e84-ae0d-4a46bc88b4e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameKey Surgical Mr. Clear Anti-Fog
Version Model NumberAF-031
Catalog NumberAF-031
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771037859 [Primary]
GS110849771037856 [Package]
Contains: 00849771037859
Package: Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCTAnti Fog Solution And Accessories, Endoscopy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-01
Device Publish Date2019-07-24

Devices Manufactured by KEY SURGICAL, INC.

10724995225022 - Electro Lube2024-10-11 Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
00849771048190 - NA2024-10-11 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 6-inch long
00849771052562 - Key Surgical Pipe Cleaners2024-10-11 Pipe Cleaner, 1/8-inch Cotton, 50 feet
00849771050131 - NA2024-10-11 Steinmann Pins, Double diamond, threaded, .177-inch (4.5mm) diameter, 9-inch long
50849771050563 - NA2024-10-11 K-Wire Covers, Sterile, White, 2 per package
50849771050624 - NA2024-10-11 Pin Covers, Sterile, Lavender, 2 per package
50849771050655 - NA2024-10-11 Pin Covers, Sterile, Orange, 0.177-inch, 2 per package
00849771048503 - NA2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm
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