FDA.report

Instrapac

Primary DI
05010058184367
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8436
Catalog number
8436
Device description
Instrapac Blacks Nail File Double Ended - Fine Arrow Head File X50
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

Related Records

Contact Domains

Product Codes

CodeName
GEOFile, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEOFile, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058184367PackageGS150In Commercial Distribution
05010058084360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058184367050100581843675010058184367
05010058084360050100580843605010058084360

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of direct sunlight

Sterilization Methods

Method

Contacts

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

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05010058178885Instrapac788878882025-09-11
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05010058179660Instrapac796679662025-09-11
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05010058181977Instrapac819781972025-09-11
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05010058183605Instrapac836083602025-09-11
05010058184671Instrapac846784672025-09-11
05010058177840Instrapac778477842025-06-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05010058178595InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
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
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00840319735268Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735275Hayden MedicalHayden Medical, Inc.GEO2023-03-17
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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
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00888118072481FILEKLS-Martin L.P.GEO2018-09-26
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M2748421001Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-03-01
H834PM44090Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-02-26
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