FDA.reportPublic FDA data

RIGICON SURGICAL RETRACTOR

Primary DI
00850015358746
Brand
RIGICON SURGICAL RETRACTOR
Company
Rigicon, Inc.
Model
RSRK-1000
Catalog number
RSRK-1000
Device description
Rigicon® Surgical Retractor
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015358746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015358746008500153587468500153587460850015358746

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, single-useA sterile, frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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
00850015358449Rigicon HL Dilator 10 – 12 mm RSUD-1012RSUD-10122024-02-02
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
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00810143904659SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904680SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904697SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904703SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904710SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904727SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904918SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904956SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905045SURGIPROSSurgipros, LLCGAD2026-07-30