Pratt Dilator Extra Large 030876

GUDID M803030876

Pratt Dilator Extra Large 65-67 Fr (21.6-22.3 mm)

MEDGYN PRODUCTS, INC.

Fixed-diameter cervical dilator, reusable

• Primary Device ID: M803030876
• NIH Device Record Key: 0e2ff826-f28a-476e-aada-5c409a8543bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pratt Dilator Extra Large
• Version Model Number: Pratt Dilator Extra Large 65-67 Fr (21.6-22.3 mm)
• Catalog Number: 030876
• 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	M803030876 [Primary]

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

Sterilization

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

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

Moist Heat or Steam Sterilization

[M803030876]

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

On-Brand Devices [Pratt Dilator Extra Large]

• M803030879: Pratt Dilator Extra Large 77-79 Fr (25.6-26.3 mm)
• M803030877: Pratt Dilator Extra Large 69-71 Fr (23-23.6 mm)
• M803030876: Pratt Dilator Extra Large 65-67 Fr (21.6-22.3 mm)
• M803030875: Pratt Dilator Extra Large 61-63 Fr (20.3-21 mm)
• M803030874: Pratt Dilator Extra Large 57-59 Fr (19-19.6 mm)
• M803030873: Pratt Dilator Extra Large 53-55 Fr (17.6-18.3 mm)
• M803030872: Pratt Dilator Extra Large 49-51 Fr (16.3-17 mm)
• M803030871: Pratt Dilator Extra Large 45-47 Fr (15-15.6 mm)