FDA.report

Mastel Precision Surgical Instruments, Inc.

Primary DI
00642356200040
Brand
Mastel Precision Surgical Instruments, Inc.
Company
Mastel Precision Surgical Instruments, Inc.
Model
20.110.0322
Catalog number
20.110.0322
Device description
OZM Marker No Cross Hairs - 3.25mm Thornton
Published
2022-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HMRMarker, Ocular

Product Code Classifications

CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00642356200040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356200040006423562000406423562000400642356200040

GMDN Terms

TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
18006578057sales@mastel.com

Regulatory Flags

DUNS number
789897865
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00642356001623Mastel Surgical Inc.10.313.30012025-08-18
00642356001050SteriBestCP1038D1-P-1S/LCP1038D1-P-1S/L2025-07-10
00642356001067SteriBestCP1038D1-P-3S/LCP1038D1-P-3S/L2025-07-10
00642356001074SteriBestCP1038D1-SBCP1038D1-SB2025-07-10
00642356001081SteriBestCP1038D2-SBCP1038D2-SB2025-07-10
00642356001098SteriBestCP1038D1-NM-SBCP1038D1-NM-SB2025-07-10
00642356001104SteriBestCP1038S-NM-SBCP1038S-NM-SB2025-07-10
00642356001111SteriBestCP1038S-SBCP1038S-SB2025-07-10
00642356001128SteriBestCP471D1CP471D12025-07-10
00642356001135SteriBestCP471D1-P-1S/LCP471D1-P-1S/L2025-07-10
00642356001142SteriBestCP471D1-P-3S/L CP471D1-P-3S/L 2025-07-10
00642356001159SteriBestCP471D1-SBCP471D1-SB2025-07-10
00642356001166SteriBestCP471SCP471S2025-07-10
00642356001173SteriBestCP471S-DK-2 00642356001173 2025-07-10
00642356001180SteriBestCP471S-DK-3CP471S-DK-32025-07-10
00642356001197SteriBestCP471S-DK-4CP471S-DK-42025-07-10
00642356001203SteriBestCP471S-DK-5CP471S-DK-52025-07-10
00642356001210SteriBestCP471S-SBCP471S-SB2025-07-10
00642356001227SteriBestCP614-DK-1CP614-DK-12025-07-10
00642356001234SteriBestCP614-DK-2CP614-DK-22025-07-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04
00194613001964MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613002688MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613040093MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613042431MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049249MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049539MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049706MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049775MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049782MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049799MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049805MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613056834MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613086978MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613086985MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102463MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102524MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102531MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102647MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613106256MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01