FDA.reportPublic FDA data

Millennium

Primary DI
00190776418489
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-SILICONTUBE
Device description
Silicone Insert Only for part #1-450141
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBNGag, Mouth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776418489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776418489001907764184891907764184890190776418489

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. 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
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26
00190776437114Millennium1-516440-6752026-10-26
00190776437121Millennium1-516450-6752026-10-26
00190776437138Millennium1-516460-6752026-10-26
00190776437145Millennium1-508001H2026-10-26
00190776437152Millennium1-508002H2026-10-26
00190776437169Millennium1-508003H2026-10-26
00190776439743Millenium85-710191572026-10-26
00190776439750Millenium85-650112602026-10-26
00190776439767Millenium85-650112642026-10-26
00190776439774Millenium85-250039002026-10-26
00190776439781Millenium85-530183372026-10-26
00190776439798Millenium85-200803072026-10-26
00190776439804Millenium85-200803122026-10-26
00190776436902Millennium1-5053602026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141548140010Carnegie Surgical LLCCarnegie Surgical LLCKBN2026-10-08
G141548140020Carnegie Surgical LLCCarnegie Surgical LLCKBN2026-10-07
G141548131100Carnegie Surgical LLCCarnegie Surgical LLCKBN2026-09-30
G8791062340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
G8791062360DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
G8791062380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
00190776405755MillenniumAvalign Technologies, Inc.KBN2026-07-24
14026704810069PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810076PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810083PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
ESAM4011541STOMA®Storz am Mark GmbHKBN2022-11-07
ESAM3725121STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740111STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740141STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033001STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033011STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033021STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033031STOMA®Storz am Mark GmbHKBN2020-08-27
10889950015695Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015701Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015718Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10381780448822Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-10-23
14026704630742PILLINGTELEFLEX INCORPORATEDKBN2018-10-22
10381780506485Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780507857Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780487807Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-29
10381780487814Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487821Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487845Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780437963Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-16