FDA.reportPublic FDA data

II Ring Retractor

Primary DI
00810118341540
Brand
II Ring Retractor
Company
Automated Medical Products Corp.
Model
Horizontal Solid Bar 1”
Catalog number
1534 00 SS
Device description
Horizontal Solid Bar 1”
Published
2023-05-29
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
00810118341540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118341540008101183415408101183415400810118341540

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
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
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00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
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B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
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B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
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B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
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B7682460140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
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