FDA.reportPublic FDA data

Sklar

Primary DI
10649111325281
Brand
Sklar
Company
SKLAR CORPORATION
Model
73-1082
Device description
SKLAR POLYETHYLENE HEADBAND
Published
2019-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKFMirror, headband, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKFMirror, Headband, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111325281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911132528110649111325281

GMDN Terms#

Term, Definition table
TermDefinition
Headband, reusableA device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111347993Sklar10-15482019-05-01
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
10649111183386Sklar40-73122019-09-24
10649111183560Sklar40-73132019-09-24
10649111183713Sklar40-73142019-09-24
10649111183881Sklar40-73152019-09-24
10649111183997Sklar40-73162019-09-24
10649111184260Sklar40-73172019-09-24
10649111184420Sklar40-73182019-09-24
10649111187896Sklar40-73402019-09-24
10649111087431Sklar Instruments96-01922025-11-12
10649111225369Sklar Instruments96-10922025-11-12
10649111226281Sklar Instruments96-10972025-11-12
10649111226458Sklar Instruments96-10982025-11-12
10649111226762Sklar Instruments96-11002025-11-12
10649111226984Sklar Instruments96-11022025-11-12
10649111227370Sklar Instruments96-11052025-11-12
10649111228056Sklar Instruments96-11102025-11-12
10649111228919Sklar Instruments96-11152025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462922055evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922062evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922079evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922086evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922093evonosevonos GmbH & Co. KGHKF2026-08-14
00757770408986Bausch + LombBausch & Lomb IncorporatedHKF2025-08-04
00840183519841BR Surgical, LLCBR Surgical, LLCHKF2023-03-24
04045396214545clar N 55, LED 6 V, incl. lithium batteriesRudolf Riester GmbHHKF2021-07-19
M6334801100JEDMEDJEDMED INSTRUMENT COMPANYHKF2020-09-01
M6334801200JEDMEDJEDMED INSTRUMENT COMPANYHKF2020-09-01
00840183503697BR Surgical, LLCBR Surgical, LLCHKF2020-08-25
10649111324116SklarSKLAR CORPORATIONHKF2019-03-13
10649111325090SklarSKLAR CORPORATIONHKF2019-03-13