FDA.reportPublic FDA data

Sklar

Primary DI
10649111444098
Brand
Sklar
Company
SKLAR CORPORATION
Model
49-4736
Device description
HARRIS EXTRACTING FORCEPS SIZE 18L
Published
2019-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10649111444098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911144409810649111444098

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7300TBS BASICSACME ENTERPRISE.EMG2026-05-22
G14933001F07TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933002F08TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933010F07TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933011F08TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933012F09TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933020F08TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933021F09TBS DentalACME ENTERPRISE.EMG2026-03-02
00840018672680Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672697Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672703Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672710Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672727Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672734Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672741Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672758Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672765Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672772Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672789Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672796Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018665453Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
00840018665613Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
00840018665620Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
00840018665637Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLCW.H. Holden, Inc.EMG2026-01-06
D9288311120CROWN REMOVER - BAUERW.H. Holden, Inc.EMG2026-01-05
00841336100466Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11
00841336100657Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11
00841336100664Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11
00841336100671Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11