Ocular Exam Neonatal Speculum N6500

GUDID 00812594012518

Disposable Neonatal Speculum

NEOTECH PRODUCTS, INC.

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• Primary Device ID: 00812594012518
• NIH Device Record Key: 5fb490d4-76ad-4d0e-bf51-20ec9bb400ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocular Exam Neonatal Speculum
• Version Model Number: 10812594012515
• Catalog Number: N6500
• Company DUNS: 198013435
• Company Name: NEOTECH PRODUCTS, INC.
• Device Count: 20
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812594012518 [Unit of Use]
GS1	10812594012515 [Primary]

FDA Product Code

• FXG: Specula Accessories

Sterilization

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

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

[00812594012518]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-22
• Device Publish Date: 2021-06-14

Devices Manufactured by NEOTECH PRODUCTS, INC.

• 00812594011405 - Little Sucker Cover: 2022-05-31 Protective Cover (Qty. 50)
• 10812594010795 - Meconium Aspirator: 2022-01-24
• 10812594010818 - Meconium Aspirator Tinted: 2022-01-24
• 10812594012584 - NeoBond Shapes (Hearts) (N7426): 2022-01-24
• 00812594010330 - NeoBond: 2021-06-23 Hydrocolloid Strip
• 00812594011603 - NeoBond: 2021-06-23 Hydrocolloid Roll - 1" x 15' Roll
• 00812594012198 - EZCare Softouch - Pink: 2021-06-23 Trach Holder 6" - Pink
• 00812594012204 - EZCare Softouch - Pink: 2021-06-23 Trach Holder 7" - Pink