Dilateria

GUDID 60888937003330

Hygroscopic cervical dilator

Primary Device ID	60888937003330
NIH Device Record Key	257e9a5a-b822-4cec-8d38-28faa055c138
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dilateria
Version Model Number	MX240
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 Issuing Agency	Device ID
GS1	00888937003338 [Primary]
GS1	60888937003330 [Package] Contains: 00888937003338 Package: [1 Units] In Commercial Distribution

HDY	Dilator, Cervical, Hygroscopic-Laminaria

Steralize Prior To Use	false
Device Is Sterile	false

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