Pratt Dilator 030858

GUDID M803030858

Pratt Dilator 41-43 Fr (13.5-14.2 mm)

MEDGYN PRODUCTS, INC.

Fixed-diameter cervical dilator, reusable

• Primary Device ID: M803030858
• NIH Device Record Key: 15335af1-d48d-438d-a753-092df5b8cb42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pratt Dilator
• Version Model Number: Pratt Dilator 41-43 Fr (13.5-14.2 mm)
• Catalog Number: 030858
• 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	M803030858 [Primary]

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

Sterilization

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

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

Moist Heat or Steam Sterilization

[M803030858]

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]

• M803030859: Pratt Dilator 9-11 Fr (3-3.6 mm)
• M803030858: Pratt Dilator 41-43 Fr (13.5-14.2 mm)
• M803030857: Pratt Dilator 37-39 Fr (12.2-12.9 mm)
• M803030856: Pratt Dilator 33-35 Fr (10.9-11.6mm)
• M803030855: Pratt Dilator 29-31 Fr (9.6-10.2 mm)
• M803030854: Pratt Dilator 25-27 Fr (8.3-9 mm)
• M803030853: Pratt Dilator 21-23 Fr (7-7.6 mm)
• M803030852: Pratt Dilator 17-19 Fr (5.6-6.3 mm)
• M803030851: Pratt Dilator 13-15 Fr (4.3-4.6 mm)