FDA.report

Sklar

Primary DI
10649111160608
Brand
Sklar
Company
SKLAR CORPORATION
Model
49-3120
Device description
PLASTER AND COMPOUND KNIFE
Published
2019-05-10
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

Related Records

Product Codes

CodeName
EMFKNIFE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10649111160608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1064911116060810649111160608

GMDN Terms

TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

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

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