FDA.reportPublic FDA data

Lenticule Forceps Tips(20G)

Primary DI
00883475708530
Brand
Lenticule Forceps Tips(20G)
Company
CHARMANT INC.
Model
37-0035A
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
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883475708530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883475708530008834757085308834757085300883475708530

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue surgical forceps probe-tip, reusableA distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). 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
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
04059453116635Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNR2026-08-25
00190776426576MillenniumAvalign Technologies, Inc.HNR2026-08-19
00190776426774MillenniumAvalign Technologies, Inc.HNR2026-08-19
00198506093975ELMED INCORPORATEDELMED INCORPORATEDHNR2026-08-18
G346EA41HSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-08-14
00190776411480MillenniumAvalign Technologies, Inc.HNR2026-08-07
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNR2026-08-07
B382SD9028531640Surgical DirectSurgical Direct, Inc.HNR2026-08-07
G22312552000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-08-03
00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
00190776405854MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776405878MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776398675MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403690MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403737MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776398668MillenniumAvalign Technologies, Inc.HNR2026-07-16
00190776398699MillenniumAvalign Technologies, Inc.HNR2026-07-16
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13