FDA.reportPublic FDA data

PTL-RETRACTOR SYSTEM

Primary DI
03613720235774
Brand
PTL-RETRACTOR SYSTEM
Company
MEDICREA INTERNATIONAL
Model
A18101850
Device description
MEDIAL/LATERAL BLADE 18mm x 50mm
Published
2017-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
03613720235774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720235774036137202357743613720235774

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720249832PASS TLA220302002017-01-31
03613720286875UNiD OCTB33243600-01B33243600-012021-08-19
03613720286882UNiD OCTB33243500-01B33243500-012021-08-19
03613720286899UNiD OCTB33143600-01B33143600-012021-08-19
03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
03613720286936UNiD RODB33136012-01B33136012-012021-08-19
03613720286943UNiD RODB33236012-01B33236012-012021-08-19
03613720268451UNiD RODB33125512-01B33125512-012017-06-12
03613720268468UNiD RODB33125512-02B33125512-022017-06-12
03613720268628UNiD RODB33225512-01B33225512-012017-06-12
03613720268635UNiD RODB33225512-02B33225512-022017-06-12
03613720268963UNiD RODB33126012-01B33126012-012017-08-28
03613720268970UNiD RODB33126012-02B33126012-022017-08-28
03613720269137UNiD RODB33226012-01B33226012-012017-08-28
03613720269144UNiD RODB33226012-02B33226012-022017-08-28
03613720269304UNiD OCTB33123500-01B33123500-012017-09-12
03613720269311UNiD OCTB33123500-02B33123500-022017-09-12
03613720269397UNiD OCTB33223500-01B33223500-012017-09-12
03613720269403UNiD OCTB33223500-02B33223500-022017-09-12
03613720286585UNiD MISB33155522-01B33155522-012021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G141554311025S0Carnegie Surgical LLCCarnegie Surgical LLCGAD2023-02-13