FDA.reportPublic FDA data

Sklar

Primary DI
10649111454738
Brand
Sklar
Company
SKLAR CORPORATION
Model
66-6336
Device description
BONACCOLTO STRABISMUS FCP SMTH
Published
2019-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111454738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911145473810649111454738

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic strabismus scissorsA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the muscles of the eye during strabismus surgery. It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes. It is not intended for intraocular surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G04320061G0GEIZBear-Ent, LLCHNR2026-05-26
G04320062G0GEIZBear-Ent, LLCHNR2026-05-26
G04320065G0GEIZBear-Ent, LLCHNR2026-05-26
G04320067G0GEIZBear-Ent, LLCHNR2026-05-26
G04320068G0GEIZBear-Ent, LLCHNR2026-05-26
00041533986522Bruder KarpeckiThe Hilsinger Company Parent, LlcHNR2026-05-22
04251047910340Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047910357Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047911552Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047911675Utrata Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047913990Kelman-McPherson Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047917905McPherson Needle HolderA1 Medical GmbHHNR2026-05-22
04251047918261Castroviejo Needle HolderA1 Medical GmbHHNR2026-05-22
04251047919336Jakobi Needle HolderA1 Medical GmbHHNR2026-05-22
04251047925252Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047925399Ergo Grip Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047925658Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047928383Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047931581Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047932250Micro Gripping ForcepsA1 Medical GmbHHNR2026-05-22
04251047932281ILM ForcepsA1 Medical GmbHHNR2026-05-22
04251047933165SIGNUM LEHNER MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933172SIGNUM GIANETTI MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933189SIGNUM INAMURA MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047934407Alio MICS Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047934711Gerten DMEK Rhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047936418Gerten Iridectomy ForcepsA1 Medical GmbHHNR2026-05-22
24026704941661PILLINGTELEFLEX INCORPORATEDHNR2026-03-23
G346EA0323SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-03-12
00840319758854Hayden MedicalHayden Medical, Inc.HNR2026-03-06