FDA.report

ELMED

Primary DI
00842180100503
Brand
ELMED
Company
ELMED INCORPORATED
Model
5571-08UD
Catalog number
5571-08UD
Device description
ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, MALIS BAYONET W/IRRIGATION, 7 3/4" (19.5CM) INSULATED, CURVED UP, O.5 MM TIP
Published
2016-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BWAUnit, Electrosurgical Andcoagulation, With Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BWAUnit, Electrosurgical And Coagulation, With AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180100503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180100503008421801005038421801005030842180100503

GMDN Terms

TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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