Mastel Precision Surgical Instruments, Inc. 12.325.1092

GUDID 00642356120102

Elite II Davis Doubler, Neumann (M.I.E)

Mastel Surgical Inc.

Ophthalmic knife, reusable
Primary Device ID00642356120102
NIH Device Record Keye54cb081-c75c-401a-b103-ea68e38b9afd
Commercial Distribution Discontinuation2024-12-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMastel Precision Surgical Instruments, Inc.
Version Model Number12.325.1092
Catalog Number12.325.1092
Company DUNS789897865
Company NameMastel 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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100642356120102 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


[00642356120102]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-09-26
Device Publish Date2024-12-10

Devices Manufactured by Mastel Surgical Inc.

00642356004389 - SteriBest2025-12-17 WOVEN WIRE MESH TRAY W/ DROP HANDLES & DOUBLE FRAME LID W/ ONE LOCK, 19" x 10" x 4"
00642356004396 - Mastel Surgical2025-12-17 MICRO INSTRUMENT TRAY 10" X 6" X 1.5"
00642356004204 - SteriBest2025-11-28 INSTRUMENT TRAY 6 X 2.5 X .75 INCL. LID, BASE, MAT
00642356001951 - SteriBest2025-10-07 8" SPRING STRINGER
00642356001968 - SteriBest2025-10-07 10" L x 2.75" W PIN LOCK INSTRUMENT STRINGER
00642356001975 - SteriBest2025-10-07 12" L x 2.75" W PIN LOCK INSTRUMENT STRINGER
00642356001982 - SteriBest2025-10-07 14" L x 2.75" W PIN LOCK INSTRUMENT STRINGER
00642356001999 - SteriBest2025-10-07 16" L x 2.75" W PIN LOCK INSTRUMENT STRINGER

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