Mastel Surgical Inc. 20.110.0702

GUDID 00642356004709

OZM Marker No Cross Hairs - 7.00mm Thornton

Mastel Surgical Inc.

Corneal marker, reusable
Primary Device ID00642356004709
NIH Device Record Keyd35c1127-d11e-4d7f-a5ab-b06482a0a91d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMastel Surgical Inc.
Version Model Number20.110.0702
Catalog Number20.110.0702
Company DUNS789897865
Company NameMastel Surgical 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 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

Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com
Phone1.605.343.4595
Emailsales@mastel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100642356004709 [Primary]

FDA Product Code

HMRMarker, Ocular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


[00642356004709]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-19
Device Publish Date2026-02-11

Devices Manufactured by Mastel Surgical Inc.

00642356004709 - Mastel Surgical Inc.2026-02-19OZM Marker No Cross Hairs - 7.00mm Thornton
00642356004709 - Mastel Surgical Inc.2026-02-19 OZM Marker No Cross Hairs - 7.00mm Thornton
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

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.