FDA.reportPublic FDA data

Diamatrix Ltd

Primary DI
00813059018243
Brand
Diamatrix Ltd
Company
Diamatrix
Model
F645T
Catalog number
F645T
Device description
Kershner Capsulorrhexis Forceps, Thin Triangular Grasping tips, Angled 8mm from bend to tip, Diamond knurled handle with Flat, Guide pin stop for tip alignment, 102mm total length, Titanium
Published
2022-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813059018243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059018243008130590182438130590182430813059018243

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
809555139
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810163790577Diamatrix Ltd.C6162026-05-26
00810163790553Diamatrix Ltd.G151G1512026-04-29
00813059013354Dacrios Opthalmic KnivesD3210D32102026-04-14
00810163790546Diamatrix Ltd.N04350.8N04350.82026-03-24
00813059013491Dacrios Opthalmic KnivesD3705D37052026-03-19
00810163790430Diamatrix Ltd.F003F0032025-10-21
00810163790447Diamatrix Ltd.H805-1.5H805-1.52025-10-21
00810163790454Diamatrix Ltd.H805-3H805-32025-10-21
00810163790461Diamatrix Ltd.F300S.5F300S.52025-10-21
00810163790478Inami & Co., Ltd.S-325S-3252025-10-20
00810163790423Diamatrix Ltd.C223A-25C223A-252025-10-07
00810163790416Diamatrix Ltd.F775S2025-08-06
00810163790386Diamatrix Ltd.C119-21C119-212025-06-30
00810163790393Diamatrix Ltd. H188FH188F2025-06-30
00810163790409Diamatrix Ltd.C027-8C027-82025-06-30
00810163790348Diamatrix Ltd.F002F0022025-06-13
00810163790317Diamatrix Ltd.H854H8542025-06-06
00810163790324Diamatrix Ltd.IT-.5-CIT-.5-C2025-06-06
00810163790331Diamatrix Ltd.F445S.5F445S.52025-05-27
00810163790355Diamatrix Ltd.F040-1.2F040-1.22025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223M111991S0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-10-01
00190776432942MillenniumAvalign Technologies, Inc.HNR2026-09-30
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318338V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318345V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318451V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318468V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318475V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318482V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318499V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318598V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318673V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318680V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318697V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318703V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318741V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318772V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318833V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318857V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318932V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318949V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995317980V. MuellerSteris CorporationHNR2026-09-24
00724995318321V. MuellerSteris CorporationHNR2026-09-24
00724995318413V. MuellerSteris CorporationHNR2026-09-24
00724995318420V. MuellerSteris CorporationHNR2026-09-24