FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449012770
Brand
A.L.P.S. mvX™
Company
Tyber Medical LLC
Model
770023010
Catalog number
770023010
Device description
FRENCH BENDER
Published
2023-12-15
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449012770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449012770001964490127701964490127700196449012770

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, reusableA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933preese@tybermed.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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449024803Cannulated Headless Screw - Full Thread04.345.008TS2025-07-19
00196449024834Cannulated Headless Screw - Full Thread04.345.009TS2025-07-19
00196449024865Cannulated Headless Screw - Full Thread04.345.010TS2025-07-19
00196449024896Cannulated Headless Screw - Full Thread04.345.011TS2025-07-19
00196449024926Cannulated Headless Screw - Full Thread04.345.012TS2025-07-19
00196449024957Cannulated Headless Screw - Full Thread04.345.013TS2025-07-19
00196449024988Cannulated Headless Screw - Full Thread04.345.014TS2025-07-19
00196449025015Cannulated Headless Screw - Full Thread04.345.015TS2025-07-19
00196449025046Cannulated Headless Screw - Full Thread04.345.016TS2025-07-19
00196449025077Cannulated Headless Screw - Full Thread04.345.017TS2025-07-19
00196449025107Cannulated Headless Screw - Full Thread04.345.018TS2025-07-19
00196449025138Cannulated Headless Screw - Full Thread04.345.019TS2025-07-19
00196449025169Cannulated Headless Screw - Full Thread04.345.020TS2025-07-19
00196449025190Cannulated Headless Screw - Full Thread04.345.022TS2025-07-19
00196449025220Cannulated Headless Screw - Full Thread04.345.024TS2025-07-19
00196449025251Cannulated Headless Screw - Full Thread04.345.026TS2025-07-19
00196449025282Cannulated Headless Screw - Full Thread04.345.028TS2025-07-19
00196449025312Cannulated Headless Screw - Full Thread04.345.030TS2025-07-19
00196449025343Cannulated Headless Screw - Full Thread04.345.032TS2025-07-19
00196449025374Cannulated Headless Screw - Full Thread04.345.034TS2025-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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