Mastel Surgical Inc.

GUDID 00642356001623

Econolance Std. Groover 2.0

Mastel Precision Surgical Instruments, Inc.

Ophthalmic knife, reusable
Primary Device ID00642356001623
NIH Device Record Key8c5b04a1-b260-42b3-b6bc-749533022e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameMastel Surgical Inc.
Version Model Number10.313.3001
Company DUNS789897865
Company NameMastel Precision Surgical Instruments, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com
Phone6053414595
Emailsales@mastel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100642356001623 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


[00642356001623]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-26
Device Publish Date2025-08-18

Devices Manufactured by Mastel Precision Surgical Instruments, Inc.

00642356001623 - Mastel Surgical Inc.2025-08-26Econolance Std. Groover 2.0
00642356001623 - Mastel Surgical Inc.2025-08-26 Econolance Std. Groover 2.0
00642356001050 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-3/16" 1 SLOT PHACO HOLDER, 2 BARS
00642356001067 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-5/8" 3 SLOT PHACO HOLDER, 2 BARS
00642356001074 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, MAT
00642356001081 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, MAT, INSERT TRAY, INSERT MAT
00642356001098 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE
00642356001104 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X .75 CONSISTS OF LID, SLOTTED SHALLOW BASE
00642356001111 - SteriBest2025-07-18 INSTRUMENT TRAY ASSEMBLY 10 X 6 X .75 CONSISTS OF LID, SLOTTED SHALLOW BASE, MAT

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