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 Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution

Primary Device ID	10849771037856
NIH Device Record Key	c3589d7b-2c0a-4e84-ae0d-4a46bc88b4e5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Key Surgical Mr. Clear Anti-Fog
Version Model Number	AF-031
Catalog Number	AF-031
Company DUNS	604056226
Company Name	KEY SURGICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771037859 [Primary]
GS1	10849771037856 [Package] Contains: 00849771037859 Package: Box [20 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K993604

FDA Product Code

OCT	Anti Fog Solution And Accessories, Endoscopy

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-08-01
Device Publish Date	2019-07-24

Devices Manufactured by KEY SURGICAL, INC.

00849771047513 - NA	2024-06-07 Instrument Stringer, Surgical stainless steel, 4-inch x 2.75-inch
00849771047643 - NA	2024-04-01 Instrument Stringers, Center Lock Stringer, Surgical Stainless Steel, 6-inch x 3-inch
00849771048077 - NA	2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium
00849771048220 - NA	2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long
00849771048244 - NA	2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long
10849771050473 - NA	2024-04-01 Suture Booties, White, Sterile, 5 pair per pad
00849771051275 - NA	2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing
00849771051534 - Key Surgical Endoscope Brushes	2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead