FDA.report

Hedstreom sterile 31mm 15

Primary DI
00810118100970
Brand
Hedstreom sterile 31mm 15
Company
NUSMILE, LTD.
Model
ZHEDST3115
Device description
Blister of 6 units
Published
2023-02-15
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

Contact Domains

Product Codes

CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810118100970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118100970008101181009708101181009700810118100970

GMDN Terms

TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags

DUNS number
185497372
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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