FDA.reportPublic FDA data

Iron Intern

Primary DI
00810118340277
Brand
Iron Intern
Company
Automated Medical Products Corp.
Model
G37 Harrington Giant Sweetheart
Catalog number
GB0037
Device description
G37 Harrington Giant Sweetheart Blade
Published
2022-08-18
Public version status
New
Distribution status
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
00810118340277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118340277008101183402778101183402770810118340277

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
053435368
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
00810118343117Iron InternNathanson Hook Liver Retractor Medium TitaniumNHLR0M-TT2025-02-18
00810118343087II Ring Retractor"Malleable (Super) Retractor 1"" x 4"" with Protec1560 S0 SS2024-03-12
00810118343094II Ring Retractor"Malleable Retractor 1"" x 4"" with Protective Edg1512 00 SS2024-03-12
00810118343100II Ring Retractor"Pelvic Surgery System w 1x4"" Maleable Blades"1507 SM SS2024-03-12
00850023646927Stieber Stieber Rib Grip KitSBRBKC2023-07-19
00810118341304II Ring Retractor"Malleable Retractor 3/4"" x 4"" with Protective E1510 00 SS2023-05-29
00810118341311II Ring Retractor"Malleable Retractor 1/2"" x 4"" with Protective. 1511 00 SS2023-05-29
00810118341328II Ring Retractor"Malleable Retractor 1"" x 5"" with Protective Edg1512 00 SS2023-05-29
00810118341335II Ring Retractor"Malleable Retractor 1 1/2"" x 6"" with Protective1513 00 SS2023-05-29
00810118341342II Ring Retractor"Malleable Retractor 1"" x 9"" with Protective Edg1514 00 SS2023-05-29
00810118341359II Ring Retractor"Malleable Retractor 2"" x 6"" with Protective Edg1515 00 SS2023-05-29
00810118341366II Ring Retractor"Malleable Retractor 2"" x 8"" with Protective Edg1516 00 SS2023-05-29
00810118341373II Ring Retractor"Malleable Retractor 2"" x 10"" with Protective Ed1517 00 SS2023-05-29
00810118341380II Ring Retractor"Malleable Retractor 2"" x 12"" with Protective Ed1518 00 SS2023-05-29
00810118341397II Ring Retractor"Malleable Retractor 3"" x 6"" with Protective Edg1519 00 SS2023-05-29
00810118341403II Ring Retractor"Malleable Retractor 3"" x 7"" with Protective Edg1520 00 SS2023-05-29
00810118341410II Ring Retractor"Malleable Retractor 3"" x 8"" with Protective Edg1521 00 SS2023-05-29
00810118341427II Ring Retractor"Malleable Retractor 3"" x 9"" with Protective Edg1522 00 SS2023-05-29
00810118341434II Ring Retractor"Malleable Retractor 3"" x 10"" with Protective Ed1523 00 SS2023-05-29
00810118341441II Ring Retractor"Malleable Retractor 3"" x 12"" with Protective Ed1524 00 SS2023-05-29

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