FDA.reportPublic FDA data

MINIRAIL

Primary DI
00886385013237
Brand
MINIRAIL
Company
Stryker GmbH
Model
901-0023
Catalog number
901-0023
Device description
Hex Driver with Quick Connect 3.0mm
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385013237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385013237008863850132378863850132370886385013237

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

Regulatory Flags#

DUNS number
481999654
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
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
00841732142312GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142428GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142435GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142442GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142459GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142466GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142473GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732143074GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732145078GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732160347GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142190GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-28
00841732166721GENERIC Surgical InstrumentsCTL Medical CorporationHXX2024-12-04
00841732166738GENERIC Surgical InstrumentsCTL Medical CorporationHXX2024-12-04
00841732162792VALEOCTL Medical CorporationHXX2024-10-02
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
00810118210198Torque WrenchOsteocentric Technologies, Inc.HXX2023-10-31
00810118210259.050 Driver, ShortOsteocentric Technologies, Inc.HXX2023-10-31
00810118210266.050 Driver, LongOsteocentric Technologies, Inc.HXX2023-10-31
00810118210273.050 Driver, LatchOsteocentric Technologies, Inc.HXX2023-10-31
00810118210280Thumb KnobOsteocentric Technologies, Inc.HXX2023-10-31