FDA.report

Avalign

Primary DI
00190776046545
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM104-6682
Device description
Trocar and Cannula,
Published
2021-11-03
Public version status
New
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
KTETROCAR, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776046545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776046545001907760465451907760465450190776046545

GMDN Terms

TermDefinition
Adenoid punch forcepsA hand-held manual surgical instrument with a cutting/biting action intended to be used for excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is a metallic alligator-forceps-like instrument, often with a curved shaft, and with a distal mechanism designed to bite/punch adenoid tissue when the handles are squeezed together. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

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
true
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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