OKA Speculum

GUDID 00883475767896

CHARMANT INC.

Eyelid speculum, reusable

• Primary Device ID: 00883475767896
• NIH Device Record Key: 8f5c656f-c89f-4f50-998f-aa0f2f2754a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OKA Speculum
• Version Model Number: 37-0046
• Company DUNS: 693742728
• Company Name: CHARMANT 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: true
• 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	00883475767896 [Primary]

FDA Product Code

• HNC: Specula, Ophthalmic

Sterilization

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

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

[00883475767896]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

Devices Manufactured by CHARMANT INC.

• 00883475953299 - MS Round-Crescent-Flat: 2024-08-09
• 00883475953305 - MS Round-Crescent-Flat: 2024-08-09
• 00883475953312 - MS Round-ST-Flat: 2024-08-09
• 00883475953329 - MS Round-ST-Flat: 2024-08-09
• 00883475953411 - MS Round-ST-CV: 2024-08-09
• 00883475953428 - MS Round-ST-CV: 2024-08-09
• 00883475651300 - IOL Hook: 2023-09-26
• 00883475651324 - Capsulorrhexis Forceps: 2023-09-26