Primo Passi

Primary DI
00850018480895
Brand
Primo Passi
Company
Primo Passi LLC
Model
9229
Catalog number
SK-330
Device description
Primo Passi Baby Electric Nail Filer. Battery-operated grooming device intended for filing the fingernails and toenails of infants and young children. Compact, ergonomic, single-handed design featuring a whisper-quiet motor intended to minimize disturbance during use, including while the child is asleep. Device includes four interchangeable filing head attachments. Ultra Fine, Fine, Medium, and Ultra Gritty to accommodate different nail thicknesses and age ranges. Two-speed operation is selected via a single control button. Filing tip is soft and rounded, designed to reduce the risk of skin contact compared to traditional nail clippers or emery boards. Supplied with a compact storage case. Intended for at-home consumer use by a caregiver. Non-sterile device. Not for prescription use
Published
2026-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILWAdaptor, Grooming

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILWAdaptor, GroomingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018480895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018480895008500184808958500184808950850018480895

GMDN Terms#

Term, Definition table
TermDefinition
Assistive nail clippersA device designed to be used by a person with a disability to assist them with cutting or shortening their fingernails or toenails. It will be a robust instrument with curved cutting blades to suit the natural curvature of human nails. It comprises two hinged blades that are conjoined at the handle end of the device; these are sprung to hold them apart when not activated, and often an additional lever to accentuate the cutting action. When activated, two blades are pressed together in a chopping motion to bite off (clip) the nail that has been positioned between them.

Contacts#

Phone, Email table
PhoneEmail
888-233-3198sales@primopassi.com

Regulatory Flags#

DUNS number
080607433
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00850000125506Primo PassiXB-8732SK-2502026-09-19
00850000125469Primo PassiJPD-FR300SK-1582026-03-27
00850065139272Primo PassiXB-8791SK-3762026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840252903137Nail CareTherafin CorporationILW2023-07-10
06975463630016CILOYUYAO RIKE ELECTRIC APPLIANCE CO., LTD.ILW2023-03-30
05708590380988MATRIX M Pressalit A/SILW2023-01-26
05708590381008MATRIX MPressalit A/SILW2023-01-26
07320450124501Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124518Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124525Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124532Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124549Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124556Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124563Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124570Etac Supply Center ABEtac Supply Center ABILW2022-12-07
00749756151689DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
00749756157469DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
00749756163569DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
00749756163637DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
05708590309385PLUSPressalit A/SILW2020-06-08
05708590309408PLUSPressalit A/SILW2020-06-08
05708590309415PLUSPressalit A/SILW2020-06-08
05708590309446PLUSPressalit A/SILW2020-06-08
05708590316109PLUSPressalit A/SILW2020-06-08
05708590316123PLUSPressalit A/SILW2020-06-08
05708590316161PLUSPressalit A/SILW2020-06-08
05708590316185PLUSPressalit A/SILW2020-06-08
05708590349688MATRIX M Pressalit A/SILW2020-06-08
05708590365565MATRIX MPressalit A/SILW2020-06-08
05708590367453MATRIX MPressalit A/SILW2020-06-08