FDA.report

MEDLINE

Primary DI
20193489199762
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
EST0016M
Catalog number
EST0016M
Device description
PTFE CTD NEEDLE EXT INS 6'
Published
2021-02-28
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
20193489199762PackageGS112In Commercial Distribution
10193489199765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348919976220193489199762
1019348919976510193489199765

GMDN Terms

TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00653405013924CONMEDConmed CorporationGEI2026-03-23
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08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
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08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
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B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD8800290Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD881190Surgical DirectSurgical Direct, Inc.GEI2026-03-09