HAI Spoon

GUDID 00852194002120

Spoon, Surgical instrument for ophthalmic use

Hightech American Industrial Labs Inc

Lens spoon
Primary Device ID00852194002120
NIH Device Record Key422fa1a8-e00b-435f-8aba-fccb99e14a35
Commercial Distribution Discontinuation2025-12-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHAI Spoon
Version Model Number1
Company DUNS961991916
Company NameHightech American Industrial Labs Inc
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852194002120 [Primary]

FDA Product Code

HNBSpoon, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


[00852194002120]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-24
Device Publish Date2025-12-16

Devices Manufactured by Hightech American Industrial Labs Inc

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00852194002106 - HAI Trephine2025-12-24 Trephine, Surgical instrument for ophthalmic use
00852194002113 - HAI Specula2025-12-24 Specula, Surgical instrument for ophthalmic use
00852194002120 - HAI Spoon2025-12-24Spoon, Surgical instrument for ophthalmic use
00852194002120 - HAI Spoon2025-12-24 Spoon, Surgical instrument for ophthalmic use
00852194002144 - HAI Spatula2025-12-24 Spatula, Surgical instrument for ophthalmic use
00852194002045 - HAI Scissisors2025-12-23 Scissors, surgical instruments for ophthalmic use
00852194002052 - HAI Knife2025-12-23 Knife, surgical instrument for ophthalmic use
00852194002069 - HAI Cannula2025-12-23 Cannula, surgical instrument for ophthalmic use

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