FDA.report

New Tips Packaging

Primary DI
D757X812540
Brand
New Tips Packaging
Company
BISCO INC.
Model
X-81254
Catalog number
X-81254
Published
2018-11-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D757X812540PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags

DUNS number
053529939
Device count
1
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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