FDA.reportPublic FDA data

Avalign

Primary DI
00190776013226
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM81-1777
Device description
Spurling Kerrison
Published
2017-03-23
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

Related Records

Contact Domains

Product Codes

CodeName
HAERONGEUR, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776013226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776013226001907760132261907760132260190776013226

GMDN Terms

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

TypeValueUnit
Angle40degree
Length11Inch
Width5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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00190776417994Millennium1-1281562026-03-23
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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 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
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