FDA.report

Iron Intern

Primary DI
00810118340239
Brand
Iron Intern
Company
Automated Medical Products Corp.
Model
G31 Heaney
Catalog number
GB0031
Device description
G31 Heaney 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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810118340239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118340239008101183402398101183402390810118340239

GMDN Terms

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
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

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00810118343100II Ring RetractorPelvic Surgery System w 1x4" Maleable Blades1507 SM SS2024-03-12
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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

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