FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403048166
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
88-5300
Catalog number
885300
Device description
ENDOPLASTIC ELECTRODE HANDLE ELECTRODE HANDLE ONLY WITH SUCTION
Published
2018-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930666000REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYSnowden-Pencer1994-05-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403048166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540304816610885403048166

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

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10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
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10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

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