FDA.reportPublic FDA data

Millennium

Primary DI
00190776198664
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-2412912B
Device description
Tunneler Stainless Steel Blunt Tip
Published
2021-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776198664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776198664001907761986641907761986640190776198664

GMDN Terms#

Term, Definition table
TermDefinition
Fistula probeA slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-09
00810189451506Surgical DesignSurgical Design, Inc.GEN2026-06-06
00198506091230ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-03
G383S1061WM1413S3SURJEXSURJEXGEN2026-05-31
G383S1061WM3240913SURJEXSURJEXGEN2026-05-31
G383WM3241113SURJEXSURJEXGEN2026-05-31
00810055250929Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250936Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250943Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450264Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450271Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450288Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450295Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450301Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450318Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450325Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450332Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450349Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450356Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450363Surgical DesignSurgical Design, Inc.GEN2026-05-29
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19