NailLift

Primary DI
04997963005783
Brand
NailLift
Company
JPS CORPORATION
Model
ML4SF-E
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MQZProsthesis, Nail

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQZProsthesis, NailUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230841000NailLiftJps Corporation2024-01-22MQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04997963005783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04997963005783049979630057834997963005783

GMDN Terms#

Term, Definition table
TermDefinition
Ingrowing toenail splint/braceA non-sterile device intended to treat ingrowing toenail and the associated pain by lifting the nail at the outer edges to encourage the nail to grow out naturally. It is in the form of a band and/or wire intended to be applied on the toenail and/or clipped under the edges of the nail. It is made of polymer and/or metallic materials and is usually available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696081397
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false