FDA.reportPublic FDA data

CLARITY RETRACTOR SYSTEM

Primary DI
00191083027241
Brand
CLARITY RETRACTOR SYSTEM
Company
Rti Surgical, Inc.
Model
724-028
Catalog number
724-028
Device description
CLARITY LATERAL, 3 BLADE RETRACTOR
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00191083027241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083027241001910830272411910830272410191083027241

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
117560455
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083047676RapidEase™4564SC4564SC2023-11-03
00191083047683RapidEase™4561SC4561SC2023-11-03
00191083024554Streamline TL Spinal Fixation System10-55-PR-10010-55-PR-1002021-06-25
00191083024585Streamline TL Spinal Fixation System10-55-PR-11510-55-PR-1152021-06-25
00191083024608Streamline TL Spinal Fixation System10-55-PR-12510-55-PR-1252021-06-25
00191083024615Streamline TL Spinal Fixation System10-55-PR-13010-55-PR-1302021-06-25
00191083024639Streamline TL Spinal Fixation System10-55-PR-14010-55-PR-1402021-06-25
00191083024653Streamline TL Spinal Fixation System10-55-PR-15010-55-PR-1502021-06-25
00191083024707Streamline TL Spinal Fixation System10-55-PR-5510-55-PR-552021-06-25
00191083024745Streamline TL Spinal Fixation System10-55-PR-7510-55-PR-752021-06-25
00191083024769Streamline TL Spinal Fixation System10-55-PR-8510-55-PR-852021-06-25
00191083024776Streamline TL Spinal Fixation System10-55-PR-9010-55-PR-902021-06-25
00191083024806Streamline TL Spinal Fixation System10-55-RH-15010-55-RH-1502021-06-25
00191083024844Streamline TL Spinal Fixation System10-55-RHC-20010-55-RHC-2002021-06-25
00191083024851Streamline TL Spinal Fixation System10-55-RHC-40010-55-RHC-4002021-06-25
00191083024868Streamline TL Spinal Fixation System10-55-RHC-60010-55-RHC-6002021-06-25
00191083024875Streamline TL Spinal Fixation System10-55-RR-10010-55-RR-1002021-06-25
00191083024882Streamline TL Spinal Fixation System10-55-RR-11010-55-RR-1102021-06-25
00191083024899Streamline TL Spinal Fixation System10-55-RR-3510-55-RR-352021-06-25
00191083024905Streamline TL Spinal Fixation System10-55-RR-4010-55-RR-402021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
G453BH72800PEAK MEDICALPeak Medical Distribution Inc.GAD2026-03-30
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
08904332600681MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600704MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600629MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10
08800071700395Tiger View Kims Med Co.,Ltd.GAD2025-02-10
G141549052210Carnegie Surgical LLCCarnegie Surgical LLCGAD2025-01-17
08403207002334Anmuth Medical InternationalAnmuth Medical International, LLCGAD2024-04-10
08403207002440Anmuth Medical InternationalAnmuth Medical International, LLCGAD2024-04-10
08403207131218Anmuth Medical InternationalAnmuth Medical International, LLCGAD2023-11-16
G4533352400010PEAK MEDICALPeak Medical Distribution Inc.GAD2023-05-24