FDA.reportPublic FDA data

Iron Intern

Primary DI
00810118341168
Brand
Iron Intern
Company
Automated Medical Products Corp.
Model
Custom CCR/1 “C” Clamp with O/R Bed Rail
Catalog number
CCR1SP
Device description
Custom CCR/1 “C” Clamp with O/R Bed Rail
Published
2022-11-15
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
00810118341168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118341168008101183411688101183411680810118341168

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
00810118343124StieberG110-4 A Stieber Blade w Extra Long Ratcheted HandSB4AXL2026-05-28
00810118343131StieberG110-5 A Stieber Blade w Extra Long Ratcheted HandSB5AXL2026-05-28
00810118343148StieberG110-5.5 A Stieber Blade w Extra Long Ratcheted HaSB55XL2026-05-28
00810118343155StieberG110-6 A Stieber Blade w Extra Long Ratcheted HandSB6AXL2026-05-28
00810118343162StieberG110-8 A Super Jumbo Stieber Blade w Extra Long RaSB8AXL2026-05-28
00810118343179StieberG110-7 A Jumbo Stieber Blade w Extra Long RatcheteSB7AXL2026-05-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118343124StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343131StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343148StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343155StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343162StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343179StieberAutomated Medical Products Corp.GAD2026-05-28
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