FDA.reportPublic FDA data

Fixation Ring

Primary DI
G2231189010
Brand
Fixation Ring
Company
Medetz Surgical Instruments LLC
Model
11-8901
Device description
Nichamin Fixation Ring 14mm Fixed C Style Head, Very Fine Teeth with 10 Degree Markings, Round Knurled Handle, Stainless Steel
Published
2022-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNHRing, Ophthalmic (Flieringa)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2231189010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scleral marker, reusableA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8004205135emichaels@medetzsurgical.com

Regulatory Flags#

DUNS number
876570990
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
G22312349490Medetz Surgical Instruments12-349492026-08-03
G22312552000Medetz Surgical Instruments12-552002026-08-03
G22314029320Medetz Surgical Instruments14-0293-22026-08-03
G223140475250Medetz Surgical Instruments14-0475-252026-08-03
G223A1140970Medetz Surgical InstrumentsA11-40972026-08-03
G2231114060Medetz Surgical Instruments11-14062026-07-27
G2231119000Medetz Surgical Instruments11-19002026-07-27
G223111901T0Medetz Surgical Instruments11-1901T2026-07-27
G22312042490Medetz Surgical Instruments12-042492026-07-27
G22312240810Medetz Surgical Instruments12-240812026-07-27
G22312408910Medetz Surgical Instruments12-408912026-07-27
G223140190270Medetz Surgical Instruments14-0190272026-07-27
G223140340L0Medetz Surgical Instruments14-0340LT2026-07-27
G223140410T0Medetz Surgical Instruments14-0410-T2026-07-27
G223145830T0Medetz Surgical Instruments14-5830-t2026-07-27
G22315466860Medetz Surgical Instruments15-466862026-07-27
G2231250500Fine Thornton Fixation Ring12-250502022-02-24
G22312643590Medetz Surgical Instruments12-643592026-04-09
G2231349550Ophthalmic Scissors13-49552026-04-09
G223140461200Medetz Surgical Instruments14-0461202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047906688Hofmann-Thornton Fixation RingA1 Medical GmbHHNH2026-06-09
04251047935398Gerten Easy Liquid Bubble DMEKA1 Medical GmbHHNH2026-06-09
08435194334969AJL Vacuum Centering GuideAJL OPHTHALMIC SAHNH2026-03-12
04058935013547 Ring Fixation Fine Thornton 16Bausch & Lomb GmbHHNH2025-10-26
04058935013554 Ring Fixation Fine-Thornton 13Bausch & Lomb GmbHHNH2025-10-26
00757770418855Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00757770481835Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00190776406738MillenniumAvalign Technologies, Inc.HNH2025-07-23
G412PH95400MR PHACOCrestpoint Management LimitedHNH2025-06-09
G412PH21150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH21900MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190080MR PHACOCrestpoint Management LimitedHNH2025-06-07
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G412PH2190120MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190130MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190140MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190150MR PHACOCrestpoint Management LimitedHNH2025-06-07
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G412PH2190170MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190180MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190190MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190200MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190210MR PHACOCrestpoint Management LimitedHNH2025-06-07
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G412PH2190230MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190240MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH95000MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH9500T0MR PHACOCrestpoint Management LimitedHNH2025-06-07