FDA.reportPublic FDA data

Sklar

Primary DI
50649111392618
Brand
Sklar
Company
SKLAR CORPORATION
Model
96-2361M
Device description
PROBE W/EYE 5 INCHES STRL CS/25
Published
2019-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXBPROBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50649111392618PrimaryGS10
00649111392613Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5064911139261850649111392618
00649111392613006491113926136491113926130649111392613

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue surgical forceps probe-tip, single-useA sterile distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
25
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
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
00840606191302PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00840606191319PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00850088713558PRINCETONPrinceton Medical Group, Inc.HXB2026-08-14
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
B382SD4838920Surgical DirectSurgical Direct, Inc.HXB2026-08-03
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840183532383BR Surgical, LLCBR Surgical, LLCHXB2026-07-21
18257200046706FIREBIRD SFS,SPECIAL PRODUCTSOrthofix US LLCHXB2026-07-17
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095BENCOXCorentec Co., LtdHXB2026-04-10
10888857578197Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578203Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578630Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578647Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578654Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578661Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578678Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578685Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20