FDA.reportPublic FDA data

FILE

Primary DI
00888118085726
Brand
FILE
Company
KLS-Martin L.P.
Model
54-386-10-07
Device description
FINGERNAIL
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00888118085726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118085726008881180857268881180857260888118085726

GMDN Terms#

Term, Definition table
TermDefinition
Nail scissors, reusableA hand-held device designed specifically for cutting the nails of a patient. It is comprised of two pivoted blades with finger and thumb ring-handles, which cut the nails with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed); the blades may be curved to follow the natural curvature of human nails. It is not a pair of nail clippers. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24
00888118035882LEVEL ONE NEURO25-015-04-092016-03-24
00888118035912LEVEL ONE NEURO25-015-06-092016-03-24
00888118035943LEVEL ONE NEURO25-015-08-092016-03-24
00888118035974LEVEL ONE NEURO25-016-06-092016-03-24
00888118036018LEVEL ONE NEURO25-016-10-092016-03-24
00888118036049LEVEL ONE CMF25-017-04-092016-03-24
00888118036056LEVEL ONE CMF25-017-06-092016-03-24
00888118036063LEVEL ONE CMF25-017-08-092016-03-24
00888118036148LEVEL ONE CMF25-020-24-092016-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058078598InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058084360InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058178595InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058184367InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058081635InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
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
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
10381780509448Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
H8344028020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
00888118072481FILEKLS-Martin L.P.GEO2018-09-26
10381780409731Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409748Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409755Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409762Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124811Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124861Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124911Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02