FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955171460
Brand
AESCULAP
Company
AESCULAP IMPLANT SYSTEMS, LLC
Model
ME174R
Catalog number
ME174R
Device description
ARCADIUSXP L HEXALOBE BALL SCREWDRIVER
Published
2020-05-08
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
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955171460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955171460040469551714604046955171460

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
622600992
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
04038653399277SPECTRUMFG331TFG331T2017-01-20
04038653399284SPECTRUMFG333TFG333T2017-01-20
04038653399291SPECTRUMFG335TFG335T2017-01-20
04038653399307SPECTRUMFG337TFG337T2017-01-20
04038653399314SPECTRUMFG338TFG338T2017-01-20
04038653399321SPECTRUMFG339TFG339T2017-01-13
04038653399338SPECTRUMFG340TFG340T2017-01-13
04038653399345SPECTRUMFG341TFG341T2017-01-20
04038653399352SPECTRUMFG343TFG343T2017-01-20
04038653399369SPECTRUMFG345TFG345T2017-01-20
04038653399376SPECTRUMFG347TFG347T2017-01-20
04038653399383SPECTRUMFG349TFG349T2017-01-20
04038653399390SPECTRUMFG351TFG351T2017-01-20
04038653399406SPECTRUMFG353TFG353T2017-01-13
04038653399413SPECTRUMFG355TFG355T2017-01-20
04038653399420SPECTRUMFG356TFG356T2017-01-20
04038653399437SPECTRUMFG358TFG358T2017-01-20
04038653399444SPECTRUMFG359TFG359T2017-01-20
04038653399451SPECTRUMFG876TFG876T2017-01-20
04038653399468SPECTRUMFG877TFG877T2017-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24