FDA.reportPublic FDA data

Millennium

Primary DI
00190776084776
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
Z16073GY
Device description
Z-Clamp
Published
2017-05-22
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
HCZFORCEPS, SURGICAL, GYNECOLOGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776084776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776084776001907760847761907760847760190776084776

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). 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
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
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 HeaneyASPEN SURGICAL PRODUCTS, INC.HCZ2024-08-07
00887482040386Symmetry HeaneyASPEN SURGICAL PRODUCTS, INC.HCZ2024-08-06