FDA.reportPublic FDA data

Diamatrix

Primary DI
00813059015594
Brand
Diamatrix
Company
Diamatrix
Model
F663S-A
Device description
Utrata-Kershner Capsulorhexis Cystotome Forceps, Angled 11.5mm from bend to tip with extremely thin Sharp triangular grasping tips, Diamond knurled handle with Flat, Guide pin stop for tip alignment, 105mm total length, Stainless.
Published
2019-12-20
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
00813059015594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059015594008130590155948130590155940813059015594

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
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D5052200TENNAT TYING FORCEPS STR DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052300TENNAT TYING FORCEPS CVD DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052340MAUMENEE TYING FORCEPS STRDAUD JEE MFG. COHNR2023-01-05
G006D5052350MAUMENEE TYING FORCEPS ANGDAUD JEE MFG. COHNR2023-01-05
G006D5054000HARMS TYING FORCEPS STR STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5054100HARMS TYING FORCEPS CVD STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5051120ANIS TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-21
G006D5051130ANIS TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-21
G006D5051900FREEMAN-JAFFE LENS HOLDING FORCEPSDAUD JEE MFG. COHNR2022-12-21
G006D5052000JAFFE TYING FORCEPS STRAIGHT DAUD JEE MFG. COHNR2022-12-21
G006D5052100JAFFE TYING FORCEPS CURVED DAUD JEE MFG. COHNR2022-12-21
G006D5051000SINSKEY TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-20
G006D5051100SINSKEY TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-20
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50313000Capsulorhexis Forceps G PATTERNDAUD JEE MFG. COHNR2022-12-19
G006D504050810 CAPS FORCEPS RND HDL STR DAUD JEE MFG. COHNR2022-12-19
G006D505000910CAPSULORRHEXIS FORCEPS ROUND HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D505000990CAPSULORRHEXIS FORCEPS FOR MICRO COXIAL 2MMDAUD JEE MFG. COHNR2022-12-19
G006D506000000CAPSULORRHEXIS FORCEPS FOR MICS/MCCSDAUD JEE MFG. COHNR2022-12-19
G006D506000020CAPSULORRHEXIS FORCEPS 12MMDAUD JEE MFG. COHNR2022-12-19
G006D506000030CAPSULORRHEXIS FORCEPS 11MMDAUD JEE MFG. COHNR2022-12-19
G006D5060000510PRECHOPPER COMBO CROSS SECTION SHARP TIPDAUD JEE MFG. COHNR2022-12-19
G006D507000030CAPSULORRHEXIS FORCEPS 11MM ANGLEDDAUD JEE MFG. COHNR2022-12-19
G006D50800012340TITANIUM CAPSULORRHEXIS FORCEPS ERGONOMIC HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D508000123410TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 12MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123420TITANIUM CAPSULORRHEXIS FORCEPS ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123430TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17