FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449016709
Brand
A.L.P.S. mvX™
Company
Tyber Medical, LLC
Model
770103050
Catalog number
770103050
Device description
ANKLE SCREW RACK
Published
2023-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449016709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449016709001964490167091964490167090196449016709

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933preese@tybermed.com
+1(866)761-0933ra@tybermed.com

Regulatory Flags#

DUNS number
010968002
Device count
1
Lot or batch
true
Manufacturing date on label
true

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00196449021192VOLT™ Wrist Treatment System02.426.6472026-04-10
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00196449021253VOLT™ Wrist Treatment System04.426.2502026-04-10
00196449021260VOLT™ Wrist Treatment System04.426.2552026-04-10
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00196449021932VOLT™ Wrist Treatment System02.426.9102026-04-10
00196449021949VOLT™ Wrist Treatment System02.426.9212026-04-10

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