BR15042

GUDID 00849771051275

Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing

KEY SURGICAL, INC.

Surgical instrument/endoscope cleaning utensil, single-use
Primary Device ID00849771051275
NIH Device Record Key8b84ff1c-3d80-44da-9263-edb8d6d5372b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBR15042
Catalog NumberBR15042
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771017813 [Previous]
GS100849771051275 [Primary]

FDA Product Code

MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


[00849771051275]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-01
Device Publish Date2024-03-22

Devices Manufactured by KEY SURGICAL, INC.

00849771052159 - NA2025-08-27 Dry Endoscopy Sponge, 2-inch OD x 0.50-inch ID x 3.75-inch Long
00849771048237 - NA2025-08-19 K-Wire and Steinmann Pin Dispensers, 5/64-inch (2.0mm) diameter, Holds pins up to 12-inch long
00849771049036 - NA2025-08-19 K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long
00849771049289 - NA2025-08-19 K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long
00849771049500 - NA2025-08-19 K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch
00849771048169 - NA2025-05-08 K-Wire and Steinmann Pin Dispensers, .035 inch .9mm diameter, Holds kwires up to 6 inch long
00849771049012 - NA2025-05-08 K-Wires, Double trocar, .054-inch (1.4mm) diameter, 12-inch long
00849771049128 - NA2025-05-08 K-Wires, Single trocar, .035-inch (.9mm) diameter, 12-inch long

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