FDA.report

MILLENNIUM

Primary DI
00190776352394
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
6-4632
Device description
Bakes Common Duct Dilators
Published
2023-09-28
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

Related Records

Contact Domains

Product Codes

CodeName
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776352394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776352394001907763523941907763523940190776352394

GMDN Terms

TermDefinition
Common bile duct dilatorA hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. It typically consists of a slender hollow or solid body instrument made of metal or plastic in a cylindrical form. It is available in a variety of sizes (diameters) and flexibilities. 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
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

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00190776418045Millennium1-161762026-03-23
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00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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