FDA.reportPublic FDA data

Millennium

Primary DI
00190776100902
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
2-2803
Device description
Spinal Retractor Handle
Published
2017-05-22
Public version status
Update
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
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
00190776100902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776100902001907761009021907761009020190776100902

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retractor, self-retainingA surgical instrument for separating and/or drawing aside nervous system structures or other tissues to permit examination or intervention. Once set, this retractor maintains its set position. It is 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
false
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
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 Surgical®SYMMETRY SURGICAL INC.GZT2024-08-14
00887482045305Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482056462Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482104545Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482104866Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482104873Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105061Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105245Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105252Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105269Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105276Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105306Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105313Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07
00887482105320Symmetry Surgical®SYMMETRY SURGICAL INC.GZT2024-08-07