NA

Primary DI
H981U444822001
Brand
NA
Company
Synthes GmbH
Model
U44-482-20
Catalog number
U4448220
Device description
DOUBLE-ENDED ELEVATOR 20CM SIZE 1
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

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
10705034710907PrimaryGS10
H981U444822001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503471090710705034710907

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034579580N/AMedos International SàrlHTE2026-06-25
10705034579597N/AMedos International SàrlHTE2026-06-25
10705034579603N/AMedos International SàrlHTE2026-06-25
B8039702640ORTHOMEDORTHO-MED, INC.HTE2026-06-22
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