FDA.reportPublic FDA data

Sklar

Primary DI
10649111199110
Brand
Sklar
Company
SKLAR CORPORATION
Model
70-9181
Device description
NEGUS ADENOID CURETTE SIZE 2 8 INCHES
Published
2019-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KBJCURETTE, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111199110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911119911010649111199110

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid curette, reusableA hand-held manual surgical instrument designed for cutting and excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge that is used to facilitate the removal of the tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the adenoids. 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
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
10649111229817Sklar Instruments96-11202025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00194613048730MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048747MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048754MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048778MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048792MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048808MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048822MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048839MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048846MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048877MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613057329MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613068820MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613124014MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
04049047340003GimmiGimmi GmbHKBJ2025-05-22
04049047340010GimmiGimmi GmbHKBJ2025-05-22
04049047340027GimmiGimmi GmbHKBJ2025-05-22
04049047340034GimmiGimmi GmbHKBJ2025-05-22
04049047371595GimmiGimmi GmbHKBJ2025-05-22
04049047371601GimmiGimmi GmbHKBJ2025-05-22
04049047385509GimmiGimmi GmbHKBJ2025-05-22
04049047385516GimmiGimmi GmbHKBJ2025-05-22
04049047387497GimmiGimmi GmbHKBJ2025-05-22
00194613048709MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048716MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048761MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048815MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048860MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00840183507268BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00840183512446BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10