FDA.reportPublic FDA data

Mastel Precision Surgical Instruments, Inc.

Primary DI
00642356250410
Brand
Mastel Precision Surgical Instruments, Inc.
Company
Mastel Surgical Inc.
Model
25.266.1401
Catalog number
25.266.1401
Device description
Rings Fixation Swivel TR (Closed Rings) - 14mm Bores
Published
2022-08-23
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
00642356250410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356250410006423562504106423562504100642356250410

GMDN Terms#

Term, Definition table
TermDefinition
Eyeball fixation instrument, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. 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
00642356005812SteriBestCP471D1-SBAT01552026-07-28
00642356005645SteriBest44-0218122026-07-22
00642356002972SteriBestCP1038D1-SB80.CP1038D1-SB2025-11-06
00642356003009SteriBestCP1038D2-SB80.CP1038D2-SB2025-11-06
00642356003016SteriBestCP1038S-SB80.CP1038S-SB2025-11-06
00642356003023SteriBestCP471D1-SB80.CP471D1-SB2025-11-06
00642356003054SteriBestCP471S-SB80.CP471S-SB2025-11-06
00642356003108SteriBestCP614-SB80.CP614-SB2025-11-06
00642356003146SteriBestCP634-SB80.CP634-SB2025-11-06
00642356003160SteriBestCP778-SB80.CP778-SB2025-11-06
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
00642356002989SteriBestCP1038D1-P-1S/L80.CP1038D1-P-1S/L2025-11-06
00642356002996SteriBestCP1038D1-P-3S/L80.CP1038D1-P-3S/L2025-11-06
00642356003030SteriBestCP471D1-P-1S/L80.CP471D1-P-1S/L2025-11-06

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Primary DI, Brand, Company table
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03700483628261MORIAMORIA SAHMR2026-07-16
04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
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00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
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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