FDA.reportPublic FDA data

YAMANE Double Needle Guide

Primary DI
00883475953848
Brand
YAMANE Double Needle Guide
Company
CHARMANT INC.
Model
37-0078
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOECaliper, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883475953848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883475953848008834759538488834759538480883475953848

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic angular gauge, reusableA non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. 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
693742728
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883475708523Multi Purpose Forceps37-00352023-09-18
00883475953930Paddle tip Manipulator37-00802023-09-18
00883475953947Ball tip Manipulator37-00812023-09-18
00883475953299MS Round-Crescent-Flat22-01BNJP2024-08-01
00883475953305MS Round-Crescent-Flat22-01BNKP2024-08-01
00883475953312MS Round-ST-Flat22-02BNIP2024-08-01
00883475953329MS Round-ST-Flat22-02BNKP2024-08-01
00883475953411MS Round-ST-CV22-03BNIP2024-08-01
00883475953428MS Round-ST-CV22-03BNKP2024-08-01
00883475951370Pressure Adjustable Micro-Sucker 7S31-50572023-09-18
00883475651300IOL Hook37-00022023-09-18
00883475651324Capsulorrhexis Forceps37-00042023-09-18
00883475651331Micro Scissors(Acute tips)37-00052023-09-18
00883475651348Micro Scissors(Blunt tips)37-00062023-09-18
00883475651355Iris Forceps37-00072023-09-18
00883475651362Needle Holder37-00082023-09-18
00883475651379Wire Speculum37-00092023-09-18
00883475651386Wire Speculum with Blade37-00102023-09-18
00883475679038Micro Forceps CROSS MAX37-00112023-09-18
00883475679045Cilia Forceps CROSS MAX37-00122023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089053ELMED INCORPORATEDELMED INCORPORATEDHOE2026-03-03
00852194002090HAI CaliperHightech American Industrial Labs IncHOE2025-12-16
09348811124524INKAThe Trustee for KAISER FAMILY TRUSTHOE2025-11-28
00810207782575Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00810207782582Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00194613007409MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007423MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007430MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007454MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007508MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613051952MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613112783MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
04058935011055Castroviejo CaliperBausch & Lomb GmbHHOE2025-07-10
04058935011062Castroviejo Marking CaliperBausch & Lomb GmbHHOE2025-07-10
G412PH94030MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH94071T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
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G412PH61270MR PHACOCrestpoint Management LimitedHOE2025-05-27
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G412PH62550MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62560MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6433L0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6433R0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6434L0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6434R0MR PHACOCrestpoint Management LimitedHOE2025-05-27