FDA.reportPublic FDA data

Mastel Precision Surgical Instruments, Inc.

Primary DI
00642356200613
Brand
Mastel Precision Surgical Instruments, Inc.
Company
Mastel Surgical Inc.
Model
20.111.0651
Catalog number
20.111.0651
Device description
OZM Marker With Cross Hairs - 6.50mm Bores
Published
2022-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00642356200613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356200613006423562006136423562006130642356200613

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18006578057sales@mastel.com

Regulatory Flags#

DUNS number
789897865
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642356005041Mastel SurgicalKWR-4002026-04-13
00642356005058Mastel SurgicalKWR-6002026-04-13
00642356005065Mastel SurgicalKWR-9002026-04-13
00642356004709Mastel Surgical Inc.20.110.070220.110.07022026-02-11
00642356004389SteriBest44-0207412025-12-09
00642356004396Mastel SurgicalCP1038D1-SBAT01952025-12-09
00642356004204SteriBestCP614-SBAT02102025-11-20
00642356002972SteriBestCP1038D1-SB80.CP1038D12025-11-06
00642356002989SteriBestCP1038D1-P-1S/L80.CP1038D1-P-1S/L2025-11-06
00642356002996SteriBestCP1038D1-P-3S/L80.CP1038D1-P-3S/L2025-11-06
00642356003009SteriBestCP1038D2-SB80.CP1038D22025-11-06
00642356003016SteriBestCP1038S-SB80.CP1038S2025-11-06
00642356003023SteriBestCP471D1-SB80.CP471D12025-11-06
00642356003030SteriBestCP471D1-P-1S/L80.CP471D1-P-1S/L2025-11-06
00642356003047SteriBestCP471D1-P-3S/L80.CP471D1-P-3S/L2025-11-06
00642356003054SteriBestCP471S-SB80.CP471S2025-11-06
00642356003061SteriBestCP471S-DK-280.CP471S-DK-22025-11-06
00642356003078SteriBestCP471S-DK-380.CP471S-DK-32025-11-06
00642356003085SteriBestCP471S-DK-480.CP471S-DK-42025-11-06
00642356003092SteriBestCP471S-DK-580.CP471S-DK-52025-11-06

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