RIGICON DILATOM™ RSSC-1314

GUDID 00850033207842

Rigicon, Inc.

Corpus cavernosum dilator, reusable
Primary Device ID00850033207842
NIH Device Record Keyce83d24f-03e8-473f-87e0-720d876844bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGICON DILATOM™
Version Model Number13-14 MM
Catalog NumberRSSC-1314
Company DUNS045247683
Company NameRigicon, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033207842 [Primary]

FDA Product Code

QGAPenile Implant Surgical Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


[00850033207842]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [RIGICON DILATOM™]

008500332078809-10 MM
0085003320787307-08 MM
0085003320784213-14 MM
0085003320782810-12 MM
0085003320781111-12 MM

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