FDA.reportPublic FDA data

Avalign

Primary DI
00190776283285
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM88-1927
Device description
Darrach Acromial Lever
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
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776283285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776283285001907762832851907762832850190776283285

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00810220800249Adler Instrument CompanyAdler, Inc.GAC2026-05-26
10705034577067N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577074N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577081N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577104N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577555N/ADEPUY SPINE, LLCGAC2026-02-05
03662663083577ActivLHighridge Medical, LLCGAC2026-02-03
00842078102275Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00842078102329Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00810207783558Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783565Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783572Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783589Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783596Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783602Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783619Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783626Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783633Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783640Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783657Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783664Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783671Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00190776411367MillenniumAvalign Technologies, Inc.GAC2025-09-22
00190776410445MillenniumAvalign Technologies, Inc.GAC2025-09-11
00190776409821MillenniumAvalign Technologies, Inc.GAC2025-09-08
00190776409920MillenniumAvalign Technologies, Inc.GAC2025-09-08
B356FF131030American MedicalsAmerican MedicalsGAC2025-08-16
B356FF131050American MedicalsAmerican MedicalsGAC2025-08-16
00190776406875MillenniumAvalign Technologies, Inc.GAC2025-07-24
00190776406578MillenniumAvalign Technologies, Inc.GAC2025-07-22