NA

Primary DI
10887587078366
Brand
NA
Company
Synthes GmbH
Model
SD398.417
Catalog number
SD398417
Device description
BONE PUSHER
Published
2024-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTEELEVATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587078366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758707836610887587078366

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811078988INKAThe Trustee for KAISER FAMILY TRUSTHTE2026-03-18
10840199507723SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507730SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507747ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507754ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507761ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507778ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507785ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507792ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507808ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507815ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507877ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507969ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511447ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511454ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526540ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526557ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199545558ElevatorKOROS U.S.A., INC.HTE2024-02-05
10840199527288ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527295ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527301ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527318ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527325ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527332ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527349ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527356ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199528315ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529077Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529084Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529091Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31