FDA.reportPublic FDA data

Millennium

Primary DI
00190776127190
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-5220520
Device description
5mm Dialating Trocar, Blunt Tip
Published
2023-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HINCOAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776127190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776127190001907761271901907761271900190776127190

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776435219Millennium63-G12015NE2026-10-19
00190776435226Millennium1-3204302026-10-19
00190776435233Millennium63-G53012026-10-19
00190776435240Millennium72-9865IS2026-10-19
00190776435257Millennium1-242207C2026-10-19
00190776435264Millennium1-0101672026-10-19
00190776435271Millennium1-0201862026-10-19
00190776435288Millennium72-5223612B12026-10-19
00190776435295Millennium72-52536462026-10-19
00190776435301Millennium63-36303SP-BL2026-10-19
00190776435318Millennium92-F31012026-10-19
00190776435325Millennium1-013L2026-10-19
00190776435332Millennium1-007L2026-10-19
00190776435349Millennium1-110570-92026-10-19
00190776435356Millennium1-26582026-10-19
00190776435363Millennium1-21585-72026-10-19
00190776435370Millennium1-3602742026-10-19
00190776435387Millennium1-3602752026-10-19
00190776435394Millennium1-BIO110432026-10-19
00190776435400Millennium1-1002912026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435462MillenniumAvalign Technologies, Inc.HIN2026-10-19
00190776427986MillenniumAvalign Technologies, Inc.HIN2026-08-27
00190776427252MillenniumAvalign Technologies, Inc.HIN2026-08-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDHIN2026-07-17
00198506089381ELMED INCORPORATEDELMED INCORPORATEDHIN2026-04-02
05708265016389LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016402LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016426LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
B382SD80055210Surgical DirectSurgical Direct, Inc.HIN2026-02-12
00842180135437ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00842180135475ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00198506026027ELMED INCORPORATEDELMED INCORPORATEDHIN2025-05-22
00198506026034ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-11
00198506020841ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-05
06976860690375ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690382ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690399ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690405ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
00887482128596Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00887482128602Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00198506060731ELMED INCORPORATEDELMED INCORPORATEDHIN2024-08-26
00190776126421MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776126438MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127121MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127152MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127626MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127817MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776131661MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776142476MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776381851MillenniumAvalign Technologies, Inc.HIN2023-11-13