FDA.reportPublic FDA data

RIGICON DILATOM™

Primary DI
00850033207811
Brand
RIGICON DILATOM™
Company
Rigicon, Inc.
Model
11-12 MM
Catalog number
RSSC-1112
Published
2024-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QGAPenile Implant Surgical Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGAPenile Implant Surgical AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033207811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033207811008500332078118500332078110850033207811

GMDN Terms#

Term, Definition table
TermDefinition
Corpus cavernosum dilator, reusableA non-sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of metal (e.g., stainless steel); it is available in a set of graduated sizes that are applied in succession. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
045247683
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033207828RIGICON DILATOM™10-12 MMRSSC-10122024-06-26
00850033207842RIGICON DILATOM™13-14 MMRSSC-13142024-06-26
00850033207873RIGICON DILATOM™ 07-08 MMRSSC-07082024-06-26
00850033207880RIGICON DILATOM™9-10 MMRSSC-09102024-06-26
00850015358289Rigicon Stainless Steel Furlow Insertion ToolRSSF-1000RSSF-10002024-02-02
00850015358296Rigicon Stainless Steel Dilator 09-10 mmRSSD-0910 RSSD-0910 2024-02-02
00850015358302Rigicon Stainless Steel Dilator 11-12 mmRSSD-1112RSSD-11122024-02-02
00850015358319Rigicon Stainless Steel Dilator 13-14 mmRSSD-1314RSSD-13142024-02-02
00850015358326Rigicon Stainless Steel Dilator 10-12 mmRSSD-1012RSSD-10122024-02-02
00850015358395Rigicon Furlow Insertion Tool RSUF-1000RSUF-10002024-02-02
00850015358401Rigicon HL Dilator 09 – 10 mm RSUD-0910RSUD-09102024-02-02
00850015358418Rigicon HL Dilator 11 – 12 mm RSUD-1112RSUD-11122024-02-02
00850015358425Rigicon HL Dilator 13 – 14 mm RSUD-1314RSUD-13142024-02-02
00850015358432Rigicon HL Dilator 15 – 16 mm RSUD-1516RSUD-15162024-02-02
00850015358449Rigicon HL Dilator 10 – 12 mm RSUD-1012RSUD-10122024-02-02
00850015358746RIGICON SURGICAL RETRACTOR RSRK-1000RSRK-10002024-02-02
00850033207453Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mmRSSL-1012 RSSL-1012 2024-02-02
00850033207460Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mmRSSL-1014RSSL-10142024-02-02
00850033207941Rigicon Stainless Steel Dilator 15-16 mm RSSD-15162024-02-02
00850299008009RIGI10™RG1009RG10092019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956416789CARDINAL HEALTHCardinal Health 200, LLCQGA2026-04-21
10198956437012CARDINAL HEALTHCardinal Health 200, LLCQGA2026-04-09
10198956340510CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-23
50198956340518CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-23
10198956289710CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-19
50198956289718CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-19
10198956101609CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-26
50198956101607CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-26
10198956292017CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-22
50198956292015CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-22
10198956252929CARDINAL HEALTHCardinal Health 200, LLCQGA2025-12-10
50198956252927CARDINAL HEALTHCardinal Health 200, LLCQGA2025-12-10
10198956265189CARDINAL HEALTHCardinal Health 200, LLCQGA2025-11-17
50198956265187CARDINAL HEALTHCardinal Health 200, LLCQGA2025-11-17
10198956206328CARDINAL HEALTHCardinal Health 200, LLCQGA2025-10-20
10198956136281CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-22
50198956136289CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-22
10198956165373CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
10198956167193CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
50198956165371CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
50198956167191CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
10198956128682CARDINAL HEALTHCardinal Health 200, LLCQGA2025-07-29
50198956128680CARDINAL HEALTHCardinal Health 200, LLCQGA2025-07-29
00850033207828RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207842RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207873RIGICON DILATOM™ Rigicon, Inc.QGA2024-06-26
00850033207880RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00191506022181FurlowBOSTON SCIENTIFIC CORPORATIONQGA2022-11-18
00878953005386SizerBOSTON SCIENTIFIC CORPORATIONQGA2017-03-31
00878953000176Furlow Insertion ToolBOSTON SCIENTIFIC CORPORATIONQGA2014-09-25