FDA.report

Total-Comfort Clear Soft Tip Aspirators White Tubing

Primary DI
00723896009901
Brand
Total-Comfort Clear Soft Tip Aspirators White Tubing
Company
PRACTICON, INC.
Model
K2900-BTS155TC
Catalog number
70-24911 WHI
Device description
ard plastic tip saliva ejectors are just that-hard! They pinch lingual surfaces, jab the mandible and aspirate tender tissue. Here is a truly comfortable solution-so comfortable, it's patented! Total-Comfort Soft Tip Aspirators feature cushioned, flexible, patient-friendly tips. Tested and proven to be gentle on soft tissue and bone while reducing soft tissue aspiration. Elastic tips are securely bonded for safety. 100% non-latex. 6" long. 100 aspirators per bag with white or clear tubing.
Published
2018-07-19
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
00723896009901PackageGS110In Commercial Distribution
00723896009895PrimaryGS10
00723896001257Unit of UseGS10

GMDN Terms

TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
100
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
false
Sterilization required before use
false

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