FDA.reportPublic FDA data

SCHARF

Primary DI
08681506801180
Brand
SCHARF
Company
SCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETI
Model
blades cts
Catalog number
57-100-11
Device description
blades cutting 1.1
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08681506801180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08681506801180086815068011808681506801180

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic angular gauge, reusableA non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533150623
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08681506800282SCHARFserrated fue punch 1mm-4mm51-010-402026-02-17
08681506800299SCHARFserrated fue punch 1mm5mm51-010-502026-02-17
08681506801500SCHARFtray for instruments29-225-022026-02-09
08681506801593Scharfhairline ruler scale70-300-002026-01-31
08681506800343SCHARFsapphire blades 1.155-100-112026-01-26
08681506800350SCHARFsapphire blades 1.155-100-112026-01-24
08681506800268SCHARFserrated fue punch 1mm-2.5mm51-010-252025-12-25
08681506800275SCHARFserrated fue punch 1mm-3.5mm51-010-352025-12-25
08681506800947SCHARFCurved extracting forceps50-400-022025-12-19
08681506800954SCHARFfoerester extrating forceps50-400-032025-12-19
08681506800961SCHARFFUE implant Forceps50-600-042025-12-19
08681506801067SCHARFstraight forceps50-700-00-102025-12-19
08681506800060SCHARFserrated fue punch 0.75-2.5mm51-075-252025-12-09
08681506800077SCHARFserrated fue punch 0.75-3.5mm51-075-352025-12-09
08681506800091SCHARFSerrated Fue punch 0.75-5mm51-075-502025-12-09
08681506800107SCHARFserrated fue punch 0.8-2.5mm51-008-252025-12-09
08681506800114SCHARFserrated fue punch 0.8-3.5mm51-008-352025-12-09
08681506800121SCHARFserrated fue punch 0.8-4mm51-008-402025-12-09
08681506800138SCHARFserrated fue punch 0.8-5mm51-008-502025-12-09
08681506800145SCHARFserrated fue punch 0.85-2.5mm51-085-252025-12-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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