FDA.report

Surgical Aspirator Tip

Primary DI
00616784221632
Brand
Surgical Aspirator Tip
Company
DYNAREX CORPORATION
Model
2216
Device description
Surgical Aspirator Tip 1/8", white
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784221632PackageGS1100In Commercial Distribution
00616784221625PrimaryGS10
00616784221618Unit of UseGS10
00810180843447Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784221632006167842216326167842216320616784221632
00616784221625006167842216256167842216250616784221625
00616784221618006167842216186167842216180616784221618
00810180843447008101808434478101808434470810180843447

GMDN Terms

TermDefinition
ENT surgical aspiratorA sterile hand-held device intended to be used to aspirate fluid from a ENT cavity (e.g., middle ear) during a single surgical procedure. It typically consists of a flexible tube inserted into the cavity, a collection container and a connection to the wall outlet of a central vacuum system. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

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