FDA.reportPublic FDA data

Millennium

Primary DI
00190776388379
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
63-CS882225
Device description
Lowsley Prostatic Tractor, straight, 22fr caliber, 7" WL with jaws open
Published
2024-11-13
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
FGNRetractor, Non-Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776388379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776388379001907763883791907763883790190776388379

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retractorA non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.

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
09348811023018INKAThe Trustee for KAISER FAMILY TRUSTFGN2026-03-16
B382SD1471020010Surgical DirectSurgical Direct, Inc.FGN2026-02-16
B382SD934117790Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117800Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117810Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117820Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117830Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD711510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD722510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD914781140Surgical DirectSurgical Direct, Inc.FGN2025-07-23
B382SD914173650Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810000Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417811010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD9141801050Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD4834150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861300Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861400Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4862150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4871160Surgical DirectSurgical Direct, Inc.FGN2025-07-02
00810123209361Adler Instrument CompanyAdler, Inc.FGN2025-05-23
B382SD147091530Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691000Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691010Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691020Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691030Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD1417812200Surgical DirectSurgical Direct, Inc.FGN2025-02-20
B382SD1417812310Surgical DirectSurgical Direct, Inc.FGN2025-02-20
00840319757611Hayden MedicalHayden Medical, Inc.FGN2025-01-10
00840319757628Hayden MedicalHayden Medical, Inc.FGN2025-01-10