FDA.reportPublic FDA data

Avalign

Primary DI
00190776014964
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM84-2197-1
Device description
Cloward Style Blade Retractor, without lip
Published
2017-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776014964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776014964001907760149641907760149640190776014964

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch
Length75Millimeter
Width18Millimeter

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
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
10705034577241N/AMedos International SàrlGZT2026-03-20
10705034577258N/AMedos International SàrlGZT2026-03-20
10705034577265N/AMedos International SàrlGZT2026-03-20
00810123209736Adler Instrument CompanyAdler, Inc.GZT2026-01-02
00840343726454GEN2SURGIX MEDICAL LLCGZT2025-06-09
00810123209057Adler Instrument CompanyAdler, Inc.GZT2025-04-09
00810123208814Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00810123208852Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00810123208869Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00810123208876Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00840343723439GEN2SURGIX MEDICAL LLCGZT2024-09-18
00840343723712GEN2SURGIX MEDICAL LLCGZT2024-09-13
04046826464851MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
04046826464868MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
04046826464875MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
04046826464882MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
00887482157114Symmetry McCullochASPEN SURGICAL PRODUCTS, INC.GZT2024-08-14
00887482045305Symmetry Markham-MeyerdingASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482056462Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482104545Symmetry Ultra™ RevealASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482104866Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482104873Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105061Symmetry Ultra® RevealASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105245Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105252Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105269Symmetry Ultra™ RevealASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105276Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105306Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105313Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105320Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07