FDA.reportPublic FDA data

Millennium

Primary DI
00190776085346
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
10-500195
Device description
Heaney Simon Retractor
Published
2017-05-22
Public version status
Update
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
HCZFORCEPS, SURGICAL, GYNECOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCZForceps, Surgical, GynecologicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776085346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776085346001907760853461907760853460190776085346

GMDN Terms#

Term, Definition table
TermDefinition
Uterine elevatorA hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. 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
DM exempt
false
Premarket exempt
false
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
00810123209972Adler Instrument CompanyAdler, Inc.HCZ2026-03-03
00198506088834ELMED INCORPORATEDELMED INCORPORATEDHCZ2026-02-25
00198506085420ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-09-09
00198506085437ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-09-09
00198506082962ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-05-22
00198506017797ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-04-11
00198506082054ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-04-11
00198506066016ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066023ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066078ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066085ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069758ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069802ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069819ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506065828ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065835ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065842ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065859ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506072840ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-28
00198506063077ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506063145ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065453ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065613ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065620ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065811ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506017568ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-03
00840343723408GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00840343723699GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00887482077993Symmetry Surgical®SYMMETRY SURGICAL INC.HCZ2024-08-07
00887482040386Symmetry Surgical®SYMMETRY SURGICAL INC.HCZ2024-08-06