FDA.reportPublic FDA data

ENNOVATE

Primary DI
04046964700521
Brand
ENNOVATE
Company
Aesculap AG
Model
SZ343R
Catalog number
SZ343R
Device description
ENNOVATE SAGITTAL ROD BENDER RIGHT
Published
2023-03-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964700521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964700521040469647005214046964700521

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
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
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840180546178General InstrumentsALPHATEC SPINE, INC.HXW2026-05-15
00840180546192General InstrumentsALPHATEC SPINE, INC.HXW2026-05-15
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
00810111225281Instrument TrayTreace Medical Concepts, Inc.HXW2026-03-30
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
10887587077635NASynthes GmbHHXW2024-08-21
10887587077963NASynthes GmbHHXW2024-08-21
00763000733117Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-12-18
00643169273559n/aMEDTRONIC SOFAMOR DANEK, INC.HXW2022-11-14
00613994860415Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-10-10
00613994860422Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-10-10
G079C5040000010Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000020Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000030Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
08800089415212INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089417308INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089418268INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089402755Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2021-05-28
10886982277022NASynthes GmbHHXW2020-12-11
10884389956212MedlineMEDLINE INDUSTRIES, INC.HXW2020-08-21
20705034734191NASynthes GmbHHXW2019-12-18
20705034734214NASynthes GmbHHXW2019-08-20
20705034734221NASynthes GmbHHXW2019-08-20
10705034548470NADEPUY SPINE, LLCHXW2019-02-20