FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040015797
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1008118
Catalog number
1008118
Device description
"Scissor Iris 4.5"" Straight"
Published
2019-05-16
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
HNFSCISSORS, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040015797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040015797003040400157973040400157970304040015797

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800201Adler Instrument CompanyAdler, Inc.HNF2026-05-26
00192896122833Intraocular SetSONTEC INSTRUMENTS, INC.HNF2026-03-19
00198506089602ELMED INCORPORATEDELMED INCORPORATEDHNF2026-03-17
00192896122819Reynolds Tenotomy ScissorsSONTEC INSTRUMENTS, INC.HNF2026-03-10
00840319758366Hayden MedicalHayden Medical, Inc.HNF2025-12-24
00840319758373Hayden MedicalHayden Medical, Inc.HNF2025-12-24
G2231135500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
G2231135900Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
00852194002045HAI ScissisorsHightech American Industrial Labs IncHNF2025-12-15
04059453156839Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453161697Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453162632Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
00190776415167MillenniumAvalign Technologies, Inc.HNF2025-12-03
09348811004185INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-12-02
04059453117205Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-09-25
04059453119780Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-08-25
00757770406401Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770419197Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770423040Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770417780Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483563Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483570Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770486175Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770492350Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770510603Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00194613003784MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613003791MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004101MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004316MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004682MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01