FDA.reportPublic FDA data

Surgeon Sturgeon

Primary DI
00842102111716
Brand
Surgeon Sturgeon
Company
FLEXBAR MACHINE CORPORATION
Model
SST-300
Device description
Surgeons Sturgeon, Standard, 300mm x 130mm x 1.5mm
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCZRetainer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102111716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102111716008421021117168421021117160842102111716

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00842102114618Bookler Table Mounted Retractor Systems550122021-08-18
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00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11
00842102116285Mini-Bookler Table Mounted Retractor Systems55016-IL2025-07-11
00842102116292Mini-Bookler Table Mounted Retractor Systems55017-IL2025-07-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511123093Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123109Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123116Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123123Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123130Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123147Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
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