Dilateria

GUDID 60888937003323

Kit contents: One dilateria; thick (5mm), 2 gauze sponge envelops and IFU

Coopersurgical, Inc.

Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator Hygroscopic cervical dilator

• Primary Device ID: 60888937003323
• NIH Device Record Key: d7f9a65b-d955-4ed0-ab82-ed2ed086af0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dilateria
• Version Model Number: MX230
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937003321 [Primary]
GS1	60888937003323 [Package]; Contains: 00888937003321; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• HDY: Dilator, Cervical, Hygroscopic-Laminaria

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

On-Brand Devices [Dilateria]

• 60888937003330: Kit contents: One dilateria, extra thick (6mm), 2 gauze sponge envelopes and IFU
• 60888937003323: Kit contents: One dilateria; thick (5mm), 2 gauze sponge envelops and IFU
• 60888937003316: Kit contents: One dilateria, medium (4mm); 2 gauze sponge envelopes and IFU
• 60888937003309: Kit contents: One dilateria, thin (3mm), 2 gauze sponge envelopes and IFU