Home GUDID 07611819755994 NA
Primary DI 07611819755994
Brand NA
Company SYNTHES (U.S.A.) LP
Model 398.415
Catalog number 398415
Device description DOUBLE-ENDED ELEVATOR/STRAIGHT
Published 2016-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HTE ELEVATOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTE Elevator General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07611819755994 Direct Marking GS1 0 10887587041667 Primary GS1 0 H9803984150 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07611819755994 07611819755994 7611819755994 10887587041667 10887587041667
GMDN Terms# Term, Definition table Term Definition Hand-held surgical retractor, reusable A 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 832637081 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 Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09348811078988 INKA The Trustee for KAISER FAMILY TRUST HTE 2026-03-18 10840199507723 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507730 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507747 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507754 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507761 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507778 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507785 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507792 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507808 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507815 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507877 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507969 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511447 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511454 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526540 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526557 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199545558 Elevator KOROS U.S.A., INC. HTE 2024-02-05 10840199527288 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527295 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527301 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527318 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527325 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527332 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527349 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527356 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199528315 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199529077 Comfort Plus Cobb Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199529084 Comfort Plus Cobb Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199529091 Comfort Plus Cobb Elevator KOROS U.S.A., INC. HTE 2024-01-31