FDA.reportPublic FDA data

Instrapac

Primary DI
05010058184602
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8460
Catalog number
8460
Device description
Instrapac Dental Exam Pack with CPITN (WHO) Probe X40
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYCDental Prophylaxis Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYCDental Prophylaxis KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058184602PackageGS140In Commercial Distribution
05010058084605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058184602050100581846025010058184602
05010058084605050100580846055010058084605

GMDN Terms#

Term, Definition table
TermDefinition
Dental examination kitA collection of various dental instruments and the necessary materials (e.g., aspiration cannula, forceps, mirror, probe, spatula, excavator) intended to be used to perform a dental examination. It does not contain any pharmaceuticals and is not intended for surgical procedures. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry and keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags#

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05010058070158Instrapac701570152023-08-08
05010058070172Instrapac7017 Delivery Pack - 18cm/7in Forceps70172020-11-26
05010058070219Instrapac702170212022-08-12
05010058070226Instrapac702270222022-08-12
05010058070233Instrapac702370232022-08-12
05010058070240Instrapac702470242023-08-08
05010058070264Instrapac702670262024-02-28
05010058070318Instrapac703170312022-08-12
05010058070325Instrapac703270322022-08-12
05010058070332Instrapac703370332022-08-12
05010058070349Instrapac703470342022-08-12
05010058070356Instrapac703570352022-08-12
05010058070370Instrapac703770372023-08-08
05010058070424Instrapac704270422023-08-08
05010058070479Instrapac704770472022-08-12
05010058070493Instrapac704970492023-08-08
05010058070530Instrapac705370532022-08-12
05010058070578Instrapac705770572023-08-08
05010058070592Instrapac705970592022-08-12
05010058070615Instrapac706170612023-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058078147InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081406InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081666InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084582InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084599InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084605InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058178144InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058181403InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058181663InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184589InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184596InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081673InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-19
05010058181670InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-19
00850035489062Braces Treatment Starter KitzOrthonu LLCNYC2025-06-04
00850035489079Aligner Treatment Starter KitzOrthonu LLCNYC2025-06-04
05010058078123InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-05-21
05010058178120InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-05-21
05010058070158InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058071230InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058071414InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058088788InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058088849InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058170155InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058171237InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058171411InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058188785InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058188846InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
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D746ORX000051SureSmile®DENTSPLY SIRONA ORTHODONTICS INC.NYC2021-12-16