FDA.reportPublic FDA data

Instrapac

Primary DI
05010058181632
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8163
Catalog number
8163
Device description
Instrapac Podiatry Emery Boards X 200
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
05010058181632PackageGS1200In Commercial Distribution
05010058081635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058181632050100581816325010058181632
05010058081635050100580816355010058081635

GMDN Terms#

Term, Definition table
TermDefinition
Toenail file/rasp, single-useA hand-held manual instrument designed to be used by a podiatrist to file a toenail, typically to remove debris; some types are used to lift and smooth, by an abrasive action, the ingrowing edges of an ingrown toenail. It is in the form of a metallic shaft with a pointed, rasping, working end and is often double-ended with a central handle. 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
05010058178939Instrapac789378932025-05-22
05010058178946Instrapac789478942025-05-22
05010058179479Instrapac794779472025-05-22
05010058179493Instrapac794979492025-05-22
05010058182370Instrapac823782372025-05-22
05010058182387Instrapac823882382025-05-22
05010058182943Instrapac829482942025-05-22
05010058184220Instrapac842284222025-05-22
05010058184800Instrapac848084802025-05-22
05010058184992Instrapac849984992025-05-22
05010058184343Instrapac843484342025-12-16
05010058178885Instrapac788878882025-09-11
05010058179509Instrapac795079502025-09-11
05010058179660Instrapac796679662025-09-11
05010058180963Instrapac809680962025-09-11
05010058181977Instrapac819781972025-09-11
05010058182554Instrapac825582552025-09-11
05010058183605Instrapac836083602025-09-11
05010058184671Instrapac846784672025-09-11
05010058177840Instrapac778477842025-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058178595InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058184367InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
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
H8344028020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
00888118072481FILEKLS-Martin L.P.GEO2018-09-26
00888118085726FILEKLS-Martin L.P.GEO2018-09-26
M274X5124811Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124861Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124911Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124821Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M2748421001Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-03-01
H834PM44090Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-26
H834PM44100Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-26
H834PM44110Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-26
H8344013710Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-26
H8344013700Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-05
H8344028000Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-05