FDA.report

Composite Ninja Comfort Grip

Primary DI
07540172017053
Brand
Composite Ninja Comfort Grip
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
060105
Catalog number
060105
Device description
Dental Hand Instrument
Published
2020-03-19
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
false

Related Records

Contact Domains

Product Codes

CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172017053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172017053075401720170537540172017053

GMDN Terms

TermDefinition
Dental amalgam carver, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically for cutting, scraping, paring, and smoothing finishes and fashioning patterns. It will typically be a double-ended instrument made of high-grade stainless steel and have a solid blunt blade/nib of various sizes and designs with a central handle. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
DM exempt
true
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
false

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