FDA.report

Avalign

Primary DI
00190776015657
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM84226691
Device description
Spinal Discectomy Retractor, Right
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
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776015657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776015657001907760156571907760156570190776015657

GMDN Terms

TermDefinition
Neurosurgical retractor, self-retainingA surgical instrument for separating and/or drawing aside nervous system structures or other tissues to permit examination or intervention. Once set, this retractor maintains its set position. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length6Inch
Length80Millimeter
Width20Millimeter

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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