FDA.report

SINGULAR

Primary DI
20653405053290
Brand
SINGULAR
Company
Conmed Corporation
Model
000980
Catalog number
000980
Device description
SINGULAR Polypectomy Snare; Large Oval Loop, Soft Wire, Microvasive Connector
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
FDISNARE, FLEXIBLE

Product Code Classifications

CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20653405053290PackageGS110Not in Commercial Distribution
10653405053293PrimaryGS10
00653405053296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340505329020653405053290
1065340505329310653405053293
00653405053296006534050532966534050532960653405053296

GMDN Terms

TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact 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 ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes

TypeValueUnit
Length230Centimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity085 Percent (%) Relative Humidity
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-20 Degrees Fahrenheit140 Degrees Fahrenheit
Handling Environment Temperature16 Degrees Celsius27 Degrees Celsius
Handling Environment Temperature60 Degrees Fahrenheit80 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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