Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm RSSL-1014

GUDID 00850033207460

Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm

Rigicon, Inc.

Gastro-urological director
Primary Device ID00850033207460
NIH Device Record Key02a061cc-3805-406a-9320-8ce3fa8a8db8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm
Version Model NumberRSSL-1014
Catalog NumberRSSL-1014
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033207460 [Primary]

FDA Product Code

KOASurgical Instruments, G-U, Manual (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00850033207460]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-12
Device Publish Date2024-02-02

Devices Manufactured by Rigicon, Inc.

00850033207811 - RIGICON DILATOM™2024-07-04
00850033207828 - RIGICON DILATOM™2024-07-04
00850033207842 - RIGICON DILATOM™2024-07-04
00850033207873 - RIGICON DILATOM™ 2024-07-04
00850033207880 - RIGICON DILATOM™2024-07-04
00850015358289 - Rigicon Stainless Steel Furlow Insertion Tool2024-02-12 Rigicon Stainless Steel Furlow Insertion Tool
00850015358296 - Rigicon Stainless Steel Dilator 09-10 mm2024-02-12 Rigicon Stainless Steel Dilator 09-10 mm
00850015358302 - Rigicon Stainless Steel Dilator 11-12 mm2024-02-12 Rigicon Stainless Steel Dilator 11-12 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.