FDA.reportPublic FDA data

Avalign

Primary DI
00190776224714
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-1826
Device description
"Joseph Saw, straight OL 185mm (7 1/4"")"
Published
2023-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDRSAW, MANUAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776224714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776224714001907762247141907762247140190776224714

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw, rigidA hand-held manual surgical instrument typically used in orthopaedic surgery for cutting bone or other body tissue through a sawing action performed by the user. It typically consists of a metal frame with an attached handle that firmly holds an exchangeable blade usually with the cutting teeth set in a straight line; or it may have an integral blade as part of the design which can have a straight or curved cutting edge. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776433017Millennium1-3201222026-10-01
00190776433024Millennium1-5255712026-10-01
00190776433031Millennium72-52832404M2026-10-01
00190776433048Millennium1-3201042026-10-01
00190776433055Millennium1-7752SD2026-10-01
00190776433062Millennium72-31940512026-10-01
00190776433079Millennium72-317910012026-10-01
00190776433086Millennium72-180526NR2026-10-01
00190776433093Millennium72-4220812026-10-01
00190776433109Millennium1-3202132026-10-01
00190776433116Millennium1-2051362026-10-01
00190776433123Millennium72-23011WS2026-10-01
00190776433130Millennium72-2411004CM2026-10-01
00190776433147Millennium72-2411003CM2026-10-01
00190776433154Millennium72-5242002H2026-10-01
00190776433161Millennium72-5242003H2026-10-01
00190776433178Millennium72-2414002026-10-01
00190776433185Millennium92-H0498R2026-10-01
00190776432911Millennium72-2430130452026-09-30
00190776432928Millennium72-5225522B42026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411589MillenniumAvalign Technologies, Inc.GDR2026-08-07
B382SD9140251010Surgical DirectSurgical Direct, Inc.GDR2026-07-28
08403207009517Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
08403207009579Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
04049047061984GimmiGimmi GmbHGDR2025-05-20
04049047062080GimmiGimmi GmbHGDR2025-05-20
00810123208593Adler Instrument CompanyAdler, Inc.GDR2025-02-12
04049197537292RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-10-16
04049197499248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499262RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197149983RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197149990RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150002RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150125RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150163RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205146RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205153RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
00190776385774MillenniumAvalign Technologies, Inc.GDR2024-05-09
00842517107533Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00842517107540Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00888515192003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192010BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192027BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192034BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192058BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192065BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192072BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192089BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192096BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28