FDA.reportPublic FDA data

Rigicon HL Dilator 10 – 12 mm

Primary DI
00850015358449
Brand
Rigicon HL Dilator 10 – 12 mm
Company
Rigicon, Inc.
Model
RSUD-1012
Catalog number
RSUD-1012
Device description
Rigicon HL Dilator 10 – 12 mm Disposable
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015358449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015358449008500153584498500153584490850015358449

GMDN Terms#

Term, Definition table
TermDefinition
Penile prosthesis implantation instrumentA sterile, hand-held manual surgical instrument intended to be used to implant a penile prosthesis (e.g., penile prosthesis cylinder insertion within the corpora cavernosa). It may also be used during revision surgery of a penile prosthesis; it has no general surgical application. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045247683
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033207811RIGICON DILATOM™11-12 MMRSSC-11122024-06-26
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
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
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25
00190776408459MillenniumAvalign Technologies, Inc.KOA2025-08-11
00190776408121MillenniumAvalign Technologies, Inc.KOA2025-08-06
00198506084416ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084430ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084447ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084454ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05