FDA.report

Medline

Primary DI
10888277387751
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
227202RH
Catalog number
227202RH
Device description
227202 @VAPR END EFFECT ELTD W/ INTEGRAT
Published
2022-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888277387751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088827738775110888277387751

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessedA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00653405013924CONMEDConmed CorporationGEI2026-03-23
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B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
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