Primary Device ID | 60888937003309 |
NIH Device Record Key | 53975016-d81d-48c4-9cb6-348e42b25e2d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dilateria |
Version Model Number | MX210 |
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 |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Outer Diameter | 3 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00888937003307 [Primary] |
GS1 | 60888937003309 [Package] Contains: 00888937003307 Package: [1 Units] In Commercial Distribution |
HDY | Dilator, Cervical, Hygroscopic-Laminaria |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-20 |
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 |