FDA.reportPublic FDA data

Instrapac

Primary DI
05010058178595
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
7859
Catalog number
7859
Device description
Instrapac Diamond Deb Foot Dresser 18.5cm X 20
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
GEOFile, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEOFile, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058178595PackageGS120In Commercial Distribution
05010058078598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058178595050100581785955010058178595
05010058078598050100580785985010058078598

GMDN Terms#

Term, Definition table
TermDefinition
Callous file/rasp, single-useA sterile, hand-held manual instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to be rubbed back and forth over the skin to remove callouses (i.e., hardened and thickened protrusions of skin commonly known as hard skin). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18.5Centimeter

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
05010058078598InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058084360InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058184367InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058081635InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
05010058181632InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
G141514231000Carnegie Surgical LLCCarnegie Surgical LLCGEO2025-02-03
00888912088664DJO SURGICALDJO, LLCGEO2023-09-19
00888912088671DJO SURGICALDJO, LLCGEO2023-09-19
00840319735244Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735251Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735268Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735275Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735282Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735299Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735305Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735312Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735329Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735336Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319701447Hayden MedicalHayden Medical, Inc.GEO2022-07-22
10381780509448Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
H8344028020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
00888118072481FILEKLS-Martin L.P.GEO2018-09-26
00888118085726FILEKLS-Martin L.P.GEO2018-09-26
10381780409731Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409748Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409755Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409762Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124811Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124861Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124911Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02