DEFINITY CERVICAL DILATOR, 9MM DCD-901

GUDID 35420045512430

Hologic, Inc.

Cervical dilatation catheter
Primary Device ID35420045512430
NIH Device Record Keyd0dde7fd-a253-47a0-9136-5cda89ae1125
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEFINITY CERVICAL DILATOR, 9MM
Version Model NumberDCD-901
Catalog NumberDCD-901
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045512436 [Primary]
GS125420045512433 [Package]
Contains: 15420045512436
Package: BOX [5 Units]
In Commercial Distribution
GS125420045512464 [Package]
Contains: 15420045512436
Package: BOX [1 Units]
In Commercial Distribution
GS135420045512430 [Package]
Contains: 25420045512433
Package: BOX [5 Units]
In Commercial Distribution
GS135420045512461 [Package]
Contains: 25420045512464
Package: BOX [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PONCatheter, balloon, dilation of cervical canal

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[35420045512430]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-13
Device Publish Date2020-02-05

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