FDA.reportPublic FDA data

Iron Intern ARM

Primary DI
00850023646057
Brand
Iron Intern ARM
Company
Automated Medical Products Corp.
Model
Jumbo ARH 26" Iron Intern ARM
Catalog number
ARHJ26-ARM
Device description
JUMBO ARH 26" IRON INTERN AUTOMATIC RETRACTOR HOLDER Single Arm -Arm Only
Published
2022-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850023646057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023646057008500236460578500236460570850023646057

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
053435368
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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 RetractorMalleable (Super) Retractor 1" x 4" with Protectiv1560 S0 SS2024-03-12
00810118343094II Ring RetractorMalleable Retractor 1" x 4" with Protective Edge1512 00 SS2024-03-12
00810118343100II Ring RetractorPelvic Surgery System w 1x4" Maleable Blades1507 SM SS2024-03-12
00850023646927Stieber Stieber Rib Grip KitSBRBKC2023-07-19
00810118341304II Ring RetractorMalleable Retractor 3/4" x 4" with Protective Edge1510 00 SS2023-05-29
00810118341311II Ring RetractorMalleable Retractor 1/2" x 4" with Protective. Edg1511 00 SS2023-05-29
00810118341328II Ring RetractorMalleable Retractor 1" x 5" with Protective Edge1512 00 SS2023-05-29
00810118341335II Ring RetractorMalleable Retractor 1 1/2" x 6" with Protective Ed1513 00 SS2023-05-29
00810118341342II Ring RetractorMalleable Retractor 1" x 9" with Protective Edge1514 00 SS2023-05-29
00810118341359II Ring RetractorMalleable Retractor 2" x 6" with Protective Edge1515 00 SS2023-05-29
00810118341366II Ring RetractorMalleable Retractor 2" x 8" with Protective Edge1516 00 SS2023-05-29
00810118341373II Ring RetractorMalleable Retractor 2" x 10" with Protective Edge1517 00 SS2023-05-29
00810118341380II Ring RetractorMalleable Retractor 2" x 12" with Protective Edge1518 00 SS2023-05-29
00810118341397II Ring RetractorMalleable Retractor 3" x 6" with Protective Edge1519 00 SS2023-05-29
00810118341403II Ring RetractorMalleable Retractor 3" x 7" with Protective Edge1520 00 SS2023-05-29
00810118341410II Ring RetractorMalleable Retractor 3" x 8" with Protective Edge1521 00 SS2023-05-29
00810118341427II Ring RetractorMalleable Retractor 3" x 9" with Protective Edge1522 00 SS2023-05-29
00810118341434II Ring RetractorMalleable Retractor 3" x 10" with Protective Edge1523 00 SS2023-05-29
00810118341441II Ring RetractorMalleable Retractor 3" x 12" with Protective Edge1524 00 SS2023-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091100ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00198506091117ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00810220800164Adler Instrument CompanyAdler, Inc.GAD2026-05-26
00199150071685Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071692Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071708Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071760Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071777Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071807Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23