FDA.reportPublic FDA data

Avalign

Primary DI
00190776074401
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
OS5600
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
OTC
false
Sterile
false
Single use
false

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
00190776074401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776074401001907760744011907760744010190776074401

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
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 DI, Brand, Model table
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 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