HAI Spatula

GUDID 00852194002144

Spatula, Surgical instrument for ophthalmic use

Hightech American Industrial Labs Inc

General-purpose surgical spatula

• Primary Device ID: 00852194002144
• NIH Device Record Key: 3ef80aa9-b248-4564-b28a-a40f21ead49a
• Commercial Distribution Discontinuation: 2025-12-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HAI Spatula
• Version Model Number: 1
• Company DUNS: 961991916
• Company Name: Hightech American Industrial Labs Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852194002144 [Primary]

FDA Product Code

• HND: Spatula, Ophthalmic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

[00852194002144]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by Hightech American Industrial Labs Inc

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• 00852194002106 - HAI Trephine: 2025-12-24 Trephine, Surgical instrument for ophthalmic use
• 00852194002113 - HAI Specula: 2025-12-24 Specula, Surgical instrument for ophthalmic use
• 00852194002120 - HAI Spoon: 2025-12-24 Spoon, Surgical instrument for ophthalmic use
• 00852194002144 - HAI Spatula: 2025-12-24Spatula, Surgical instrument for ophthalmic use
• 00852194002144 - HAI Spatula: 2025-12-24 Spatula, Surgical instrument for ophthalmic use
• 00852194002045 - HAI Scissisors: 2025-12-23 Scissors, surgical instruments for ophthalmic use
• 00852194002052 - HAI Knife: 2025-12-23 Knife, surgical instrument for ophthalmic use
• 00852194002069 - HAI Cannula: 2025-12-23 Cannula, surgical instrument for ophthalmic use