FDA.reportPublic FDA data

Avalign

Primary DI
00190776012953
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM81-17031
Device description
Ejector Rongeur, Ceramic coat
Published
2017-03-23
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
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776012953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776012953001907760129531907760129530190776012953

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical rongeurA hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle40degree
Length8Inch
Width4Millimeter

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
00810220800089Adler Instrument CompanyAdler, Inc.HAE2026-05-26
04057034294543Punch, acc. Kerrison, K-Rex™ 40° upwards 18cm 1mm,w.ejectorGeister Medizintechnik GmbHHAE2026-05-26
04058749092523NAFehling Instruments GmbH & Co. KGHAE2026-03-05
00190776416515MillenniumAvalign Technologies, Inc.HAE2026-02-16
00887482023389SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023396SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023402SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156186SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156223SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
20887482023376SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
04058749089776NAFehling Instruments GmbH & Co. KGHAE2025-09-01
04046955741212AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741229AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741236AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741243AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741250AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741267AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741274AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741281AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741298AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741304AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741311AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741328AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741335AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741342AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741359AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741366AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741373AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741380AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741397AESCULAPAESCULAP, INC.HAE2025-08-17