FDA.reportPublic FDA data

NA

Primary DI
04058749000443
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
TXW-9X
Catalog number
TXW-9X
Device description
Screwdriver inner hexagon 3mm sterilisable
Published
2023-05-08
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058749000443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749000443040587490004434058749000443

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
800 334-5464info@fehlingsurgical.com

Regulatory Flags#

DUNS number
315028238
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058749006841NABOL-6BOL-62026-04-22
04058749007084NABOO-2BOO-22026-04-22
04058749008586NABRK-4BRK-42026-04-22
04058749009392NABSG-4BSG-42026-04-22
04058749009798NABSK-6BSK-62026-04-22
04058749010091NABSN-1BSN-12026-04-22
04058749025750NAKCA-7KCA-72026-04-22
04058749025774NAKCB-8KCB-82026-04-22
04058749040517NAMME-4MME-42026-04-22
04058749043198NAMPB-3MPB-32026-04-22
04058749043686NAMRB-3MRB-32026-04-22
04058749044669NAMRJ-4MRJ-42026-04-22
04058749044812NAMRK-9PMRK-9P2026-04-22
04058749045963NAMRV-8MRV-82026-04-22
04058749046588NAMSD-5MSD-52026-04-22
04058749049664NANBL-9NBL--2026-04-22
04058749055252NANLA-4NLA-42026-04-22
04058749075977NANUM-6NUM-62026-04-22
04058749076264NANUR-2NUR-22026-04-22
04058749076295NANUR-5NUR-52026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327651676mild Device KitSTRYKER CORPORATIONHAE2024-11-22
G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
10381780136552Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136804Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136811Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136828Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136835Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136842Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136859Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136866Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136873Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136880Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136897Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136903Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136910Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136927Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136934Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136941Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136958Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136965Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136972Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136989Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136996Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137009Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137016Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137023Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137030Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137047Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137054Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780137061Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14