FDA.reportPublic FDA data

Instrapac

Primary DI
05010058188839
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8883
Catalog number
8883
Device description
Instrapac Dental Exam Pack Plus with CPITN (WHO) Probe X40
Published
2023-08-08
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
NTCNursing Pad, Hydrogel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTCNursing Pad, HydrogelGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058188839PackageGS140In Commercial Distribution
05010058088832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058188839050100581888395010058188839
05010058088832050100580888325010058088832

GMDN Terms#

Term, Definition table
TermDefinition
Dental examination kitA collection of various sterile 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
+441909735502customerservice.worksop@vernacare.com

Regulatory Flags#

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
false
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
04719745091568Ameda ComfortGel Hydrogel PadsBENQ MATERIALS CORP.NTC2025-01-21
06975983272505MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
06975983272512MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
00810104130738Gel PackWILLOW INNOVATIONS, INC.NTC2024-02-14
00081010413073Gel PackEXPLORAMED NC7, INC.NTC2024-02-14
06975983272031MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2023-11-08
05010058088832InstrapacROBINSON HEALTHCARE LIMITEDNTC2023-08-08