FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449017454
Brand
A.L.P.S. mvX™
Company
Tyber Medical, LLC
Model
770001040A
Device description
T4 RETENTION DRIVER R
Published
2026-06-04
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449017454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449017454001964490174541964490174540196449017454

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(866)761-0933regulatory@exalta.com

Regulatory Flags#

DUNS number
010968002
Device count
1
DM exempt
false
Premarket exempt
true
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
00196449010134Anatomic Access LLIF818000292026-06-09
00196449010196Anatomic Access LLIF818000342026-06-09
00196449010288Anatomic Access LLIF818000352026-06-09
00196449035243Anatomic Access LLIF818000002026-06-09
00196449035250Anatomic Access LLIF818000012026-06-09
00196449035267Anatomic Access LLIF818000022026-06-09
00196449035281Anatomic Access LLIF818000042026-06-09
00196449035298Anatomic Access LLIF818000052026-06-09
00196449035304Anatomic Access LLIF818000062026-06-09
00196449035311Anatomic Access LLIF818000072026-06-09
00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09
00196449035489Anatomic Access LLIF818000242026-06-09
00196449035496Anatomic Access LLIF818000252026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449017348A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017379A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017386A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017393A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017553A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00841731137951TITANEX VILEX LLCLRZ2026-05-15
00841731137968TITANEX VILEX LLCLRZ2026-05-15
00841731138149TITANEX VILEX LLCLRZ2026-05-15
00841731140784TITANEX VILEX LLCLRZ2026-05-15
00841731141927TITANEX VILEX LLCLRZ2026-05-15
00841731146816TITANEX VILEX LLCLRZ2026-05-15
00841731146823TITANEX VILEX LLCLRZ2026-05-15
00841731146830TITANEX VILEX LLCLRZ2026-05-15
00841731146847TITANEX VILEX LLCLRZ2026-05-15
00841731152237DYNEX VILEX LLCLRZ2026-05-15
00841731152121DYNEX VILEX LLCLRZ2026-05-11
00841731152183DYNEX VILEX LLCLRZ2026-05-11
00841731152282DYNEX VILEX LLCLRZ2026-05-11
08800016101362Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114447Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114454Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114461Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114478Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114485Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115024Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115840Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115857Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016116014Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016144772Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163087Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28