FDA.reportPublic FDA data

HAI Forceps

Primary DI
00852194002083
Brand
HAI Forceps
Company
Hightech American Industrial Labs Inc
Model
1
Device description
Forceps, Surgical instrument for ophthalmic use
Published
2025-12-15
Public version status
New
Distribution status
Not 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
00852194002083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852194002083008521940020838521940020830852194002083

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
961991916
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852194002007EB-3000xyz12025-12-25
00852194002021EB-2000xyz12025-12-25
00852194002137SL-500012025-12-18
00852194002151AB-610012025-12-18
00852194002090HAI Caliper12025-12-16
00852194002106HAI Trephine12025-12-16
00852194002113HAI Specula12025-12-16
00852194002120HAI Spoon12025-12-16
00852194002144HAI Spatula12025-12-16
00852194002045HAI Scissisors12025-12-15
00852194002052HAI Knife12025-12-15
00852194002069HAI Cannula12025-12-15
00852194002076HAI Hook12025-12-15
00852194002014HAI CL-1000xyz clinical specular microscope12025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435318MillenniumAvalign Technologies, Inc.HNR2026-10-19
G346EA32C0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-16
00190776434885MillenniumAvalign Technologies, Inc.HNR2026-10-14
00190776434984MillenniumAvalign Technologies, Inc.HNR2026-10-14
00192896123939Bishop Harmon Tissue ForcepsSONTEC INSTRUMENTS, INC.HNR2026-10-14
G346EA41VSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-14
00757770602506Bausch + LombBausch & Lomb IncorporatedHNR2026-10-09
00190776436209MillenniumAvalign Technologies, Inc.HNR2026-10-08
00190776433734MillenniumAvalign Technologies, Inc.HNR2026-10-07
00190776436155MillenniumAvalign Technologies, Inc.HNR2026-10-07
0081748902541323ga DEX™ Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
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