FDA.reportPublic FDA data

NA

Primary DI
00840085262906
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
RZA090000
Catalog number
RZA090000
Device description
SI SCREWDRIVER, STANDARD
Published
2024-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085262906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085262906008400852629068400852629060840085262906

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
7608148047PARKER@ASTURAMEDICAL.COM

Regulatory Flags#

DUNS number
073029645
Device count
1
DM exempt
false
Premarket exempt
false
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
00840085271861NAAZA083000AZA0830002025-02-26
00840085271878NAAZA084000AZA0840002025-02-26
00840085271885NAAZA084001AZA0840012025-02-26
00840085271892NAAZA085000AZA0850002025-02-26
00840085271908NAAZA085001AZA0850012025-02-26
00840085271915NAAZA086000AZA0860002025-02-26
00840085271922NAAZA088035AZA0880352025-02-26
00840085271939NAAZA088040AZA0880402025-02-26
00840085271946NAAZA088045AZA0880452025-02-26
00840085271953NAAZA088050AZA0880502025-02-26
00840085271960NAAZA088055AZA0880552025-02-26
00840085271977NAAZA088060AZA0880602025-02-26
00840085271984NAAZA088065AZA0880652025-02-26
00840085271991NAAZA088070AZA0880702025-02-26
00840085272004NAAZA088075AZA0880752025-02-26
00840085272011NAAZA088080AZA0880802025-02-26
00840085272028NAAZA088085AZA0880852025-02-26
00840085272035NAAZA088090AZA0880902025-02-26
00840085272042NAAZA088095AZA0880952025-02-26
00840085272066NAAZA091000AZA0910002025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNH2026-05-25
00763000887070CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108141RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108158RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108165RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108172RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108189RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108196RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108202RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108219RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108226RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122529RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122536RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732131835RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145085RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145092RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117891PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117907PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117914PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2018-08-17
00841732118959PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118966PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118973PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08