FDA.report

Instrapac

Primary DI
05010058080294
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8029
Catalog number
8029
Device description
Instrapac Nail Cutter Curved Roller Spring X 20
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
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FZTCutter, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058080294PackageGS120In Commercial Distribution
05010058999749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058080294050100580802945010058080294
05010058999749050100589997495010058999749

GMDN Terms

TermDefinition
Nail clippers, single-useA sterile, hand-held device designed specifically for trimming the nails of a patient. Also known as a nail cutter, it is a robust instrument comprised of two hinged cutting blades that are conjoined at the handle end of the device. The blades are sprung to hold them apart when not activated; when activated, the two blades are pressed together in a chopping motion to bite off (clip) the nail that has been positioned between them. It is not a pair of nail scissors. 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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05010058184671Instrapac846784672025-09-11
05010058177840Instrapac778477842025-06-25

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