FDA.report

Millennium

Primary DI
00190776100735
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
R-6385
Device description
Caspar Retractor Blade, blunt,
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

Related Records

Product Codes

CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776100735PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 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