FDA.reportPublic FDA data

Avalign

Primary DI
00190776074418
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
OS5604
Device description
Tendon Stripper,
Published
2023-09-28
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
HRTSTRIPPER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776074418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776074418001907760744181907760744180190776074418

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. 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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462573N/ADoppkon GmbH & Co. KGHRT2025-12-01
04262494462559N/ADoppkon GmbH & Co. KGHRT2025-11-28
B7685410380Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
B7685410410Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
00757770409112Bausch + LombBausch & Lomb IncorporatedHRT2025-08-15
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844101117INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844101155INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844126998INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
00190776398071MillenniumAvalign Technologies, Inc.HRT2025-05-19
00190776398088MillenniumAvalign Technologies, Inc.HRT2025-05-19
00190776398095MillenniumAvalign Technologies, Inc.HRT2025-05-19
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-05-09
B7685411140Buxton BioMedicalBuxton Biomedical IncHRT2025-05-07
04047844058442INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-05-05
00840319758007Hayden MedicalHayden Medical, Inc.HRT2025-04-30
00810077631447Stripper Scribe ToolOPTICAL INTEGRITY INCHRT2025-04-11
04055207021194NARichard Wolf GmbHHRT2025-03-20
00840019969055Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14
00840019969062Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14
00840019969079Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14
00840019969086Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14