FDA.reportPublic FDA data

Sklar Instruments

Primary DI
40649111234102
Brand
Sklar Instruments
Company
SKLAR CORPORATION
Model
96-1146
Device description
DERM BIO PNCH STER DISPOSABLE 4 MM
Published
2025-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMEPUNCH, BIOPSY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111234102PackageGS125In Commercial Distribution
10649111234101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4064911123410240649111234102
1064911123410110649111234101

GMDN Terms#

Term, Definition table
TermDefinition
Skin-coring punch, single-useA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically made of high-grade stainless steel and is available in various cutting head sizes; it is not a biopsy gun. This is a single-use device.

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
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
10649111087431Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111225369Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226281Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226458Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226762Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226984Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111227370Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111228056Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111228919Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111229817Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111230585Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111487415Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111487422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111231421Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233159Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233500Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233784Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111234101Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111231422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233150Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233501Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233785Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111082726Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111234378Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111234675Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111235078Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111236594Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111072949Sklar InstrumentsSKLAR CORPORATIONEME2025-11-06
00841336113527Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336128712Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28