FDA.report

Avalign

Primary DI
00190776351540
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM88-1501
Device description
Bone File, Single ended, bayonet,
Published
2023-11-17
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776351540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776351540001907763515401907763515400190776351540

GMDN Terms

TermDefinition
Plastic surgery file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at its working end(s) designed to scrape and smooth the surface of hard tissues (e.g., bone, cartilage) during plastic surgery (e.g., rhinoplasty, face lifting). It is typically a one-piece instrument which resembles a coarse or fine file, but with sharp cutting projections instead of lines and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
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 DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19