FDA.reportPublic FDA data

Utrata Capsulorrhexis Forceps, With Cystotome Tips

Primary DI
08175700180269
Brand
Utrata Capsulorrhexis Forceps, With Cystotome Tips
Company
AURORA SURGICAL, LLC
Model
AS50-7105S
Catalog number
AS50-7105S
Device description
ECO Utrata Capsulorrhexis Forceps, With Cystotome Tips, Round Handle, 11.5mm Angled Shaft,Stainless Steel, 115mm
Published
2023-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08175700180269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700180269081757001802698175700180269

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
968368832
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08175700106733Mendez Degree GaugeAS2-0071TAS2-0071T2024-07-10
08175700106740Fixed CaliperAS2-012SAS2-012S2024-07-10
08175700106757Fixed CaliperAS2-012TAS2-012T2024-07-10
08175700106726Gimbel Mendez Beveled Degree Gauge, TitaniumAS2-011TAS2-011T2023-06-23
08175700106504Castroviejo Caliper, Stainless SteelAS2-001SAS2-001S2022-11-14
08175700106511Castroviejo Caliper, TitaniumAS2-001TAS2-001T2022-11-14
08175700106528Osher Internal Incision CaliperAS2-002AS2-0022022-11-14
08175700106535Braunstein Fixed Caliper (3.0mm-3.5mm), Stainless SteelAS2-004SAS2-004S2022-11-14
08175700106542Braunstein Fixed Caliper (3.0mm-3.5mm), TitaniumAS2-004TAS2-004T2022-11-14
08175700106559Braunstein Fixed Caliper (3.5mm-4.0mm), Stainless SteelAS2-005SAS2-005S2022-11-14
08175700106566Braunstein Fixed Caliper (3.5mm-4.0mm), TitaniumAS2-005TAS2-005T2022-11-14
08175700106573Mendez Degree Gauge, Stainless SteelAS2-006SAS2-006S2022-11-14
08175700106580Mendez Degree Gauge, TitaniumAS2-006TAS2-006T2022-11-14
08175700106597Mendez Degree Gauge, Small SizeAS2-007TAS2-007T2022-11-14
08175700106603Grooved Mendez Degree GaugeAS2-008TAS2-008T2022-11-14
08175700106627Internal Micro Incision GaugesAS2-009AS2-0092022-11-14
08175700106634Beveled Mendez Degree Gauge, Stainless SteelAS2-010SAS2-010S2022-11-14
08175700106641Beveled Mendez Degree Gauge, TitaniumAS2-010TAS2-010T2022-11-14
08175700106658Stainless Steel RulerAS2-100AS2-1002022-11-14
08175700106719Helveston Scleral RulerAS2-101AS2-1012022-11-14

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