PW10FPMT

GUDID 00849771005797

Instrument Tray Perforated 25.4 X 16.5 Inch X 1.9CM

KEY SURGICAL, INC.

Instrument tray, reusable
Primary Device ID00849771005797
NIH Device Record Keya48f52d1-0ebb-46a7-8f75-100ebb87ad59
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPW10FPMT
Catalog NumberPW10FPMT
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 Usefalse
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
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
GS100849771005797 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-10
Device Publish Date2023-11-02

Devices Manufactured by KEY SURGICAL, INC.

00849771052708 - NA2026-01-27 Plastic Sterilization Tray with Slotted Base and Silicone Mat; 7.5-inch x 2.5-inch x 0.75-inch 190.5 x 63.5 x 19mm
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

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