FDA.reportPublic FDA data

Lateral Retractor

Primary DI
00348783004762
Brand
Lateral Retractor
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9086186
Device description
Lateral Retractor with offset blades
Published
2024-08-06
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
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783004762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783004762003487830047623487830047620348783004762

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09
00348783010749Premier Jackson Original Tracheostomy Tube10343192026-06-09
00348783010756Premier Jackson Original Tracheostomy Tube10343202026-06-09
00348783010770Premier Jackson Improved Tracheostomy Tube10346102026-06-09
00348783010787Premier Jackson Improved Tracheostomy Tube10346112026-06-09
00348783010794Premier Jackson Improved Tracheostomy Tube10346122026-06-09
00348783010800Premier Jackson Improved Tracheostomy Tube10346132026-06-09
00348783010817Premier Jackson Improved Tracheostomy Tube10346142026-06-09
00348783010824Premier Jackson Improved Tracheostomy Tube10346152026-06-09
00348783010831Premier Jackson Improved Tracheostomy Tube10346162026-06-09
00348783010848Premier Jackson Improved Tracheostomy Tube10346172026-06-09
00348783010855Premier Jackson Improved Tracheostomy Tube10346182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440096Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440102Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440119Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440126Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440133Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440164Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440324Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440331Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440348Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440355Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440362Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440379Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26