FDA.reportPublic FDA data

II Ring Retractor

Primary DI
00810118341359
Brand
II Ring Retractor
Company
Automated Medical Products Corp.
Model
"Malleable Retractor 2"" x 6"" with Protective Edg
Catalog number
1515 00 SS
Device description
"Malleable Retractor 2"" x 6"" with Protective Edge"
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
00810118341359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118341359008101183413598101183413590810118341359

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091926ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038601250ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018420ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018430ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018840ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039030020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601360ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532239BR Surgical, LLCBR Surgical, LLCGAD2026-07-21