FDA.reportPublic FDA data

SCHARF

Primary DI
08681506800350
Brand
SCHARF
Company
SCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETI
Model
sapphire blades 1.1
Catalog number
55-100-11
Device description
sapphire blades used incisions for hair transplant
Published
2026-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08681506800350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08681506800350086815068003508681506800350

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
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
08681506801180SCHARFblades cts57-100-112025-12-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189450691Surgical DesignSurgical Design, Inc.EMF2026-06-06
00810189450707Surgical DesignSurgical Design, Inc.EMF2026-06-06
00198506085659ELMED INCORPORATEDELMED INCORPORATEDEMF2025-10-02
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
00860010523902VECTRRafael Medical Devices, LLCEMF2025-01-10
00842180160613ELMEDELMED INCORPORATEDEMF2023-01-30
00842180147737ELMEDELMED INCORPORATEDEMF2022-12-22
14026704810861PILLINGTELEFLEX INCORPORATEDEMF2022-12-08
00192896113701Cottle Mucosa KnifeSONTEC INSTRUMENTS, INC.EMF2022-09-15
00847399017239MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
00847399017246MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
00847399016003MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016010MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016034MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016935MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016942MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
20630140057523CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
20630140057530CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
00848782025527StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025541StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025572StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025602StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025633StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025657StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025671StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025688StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025763StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29