Pratt ExLarge 9pc Dilator Set 030870

GUDID M803030870

Pratt ExLarge 9pc Dilator Set 45-47 Fr (15-15.6 mm) - 77-79 Fr (25.6-26.3 mm)

MEDGYN PRODUCTS, INC.

Fixed-diameter cervical dilator, reusable

• Primary Device ID: M803030870
• NIH Device Record Key: 116c5db7-248e-4036-8c4e-b52c5abdfeaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pratt ExLarge 9pc Dilator Set
• Version Model Number: Pratt ExLarge 9pc Dilator Set 45-47 Fr (15-15.6 mm
• Catalog Number: 030870
• Company DUNS: 103913430
• Company Name: MEDGYN PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
HIBCC	M803030870 [Primary]

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

Sterilization

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

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

[M803030870]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

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