Delasco Electrosurgical Handpiece Sheath - SHEATHS, ELECTROSURGICAL, 26100 SAMPLE PK5. A - DERMATOLOGIC LAB AND SUPPLY, INC.

Duns Number:021628771

Device Description: SHEATHS, ELECTROSURGICAL, 26100 SAMPLE PK5. A non-sterile sheath designed to fit over mos SHEATHS, ELECTROSURGICAL, 26100 SAMPLE PK5. A non-sterile sheath designed to fit over most electrosurgical handpieces. Latex-free, 8" long with 7/8" diameter opening. Sample pack of 5. Medical device.

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More Product Details

Catalog Number

-

Brand Name

Delasco Electrosurgical Handpiece Sheath

Version/Model Number

26150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K992149,K992149

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

ad53d74b-9f4a-43ef-88dd-e7971b450b8b

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMATOLOGIC LAB AND SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 90