FDA.reportPublic FDA data

Sklar

Primary DI
10649111444081
Brand
Sklar
Company
SKLAR CORPORATION
Model
49-4735
Device description
KLEIN EX FCP AMER CURVED RND
Published
2019-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111444081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911144408110649111444081

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
G149TBSB7010TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7020TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7030TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7040TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7050TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7060TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7070TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7080TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7090TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7100TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7110TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7120TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7130TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7140TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7150TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7160TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7170TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7180TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7190TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7200TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7210TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7220TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7230TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7240TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7250TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7260TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7270TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7280TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7290TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7310TBS BASICSACME ENTERPRISE.EMG2026-05-21