FDA.report

Juneland

Primary DI
06976143660026
Brand
Juneland
Company
Suzhou Juneland Medical Co., Ltd.
Model
002
Device description
IA 3.3mm(F10) KAVO
Published
2023-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GBXCatheter, Irrigation

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976143660026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976143660026069761436600266976143660026

GMDN Terms

TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
414758527
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06976143661252Juneland0132024-10-21
06976143660040Juneland0042023-04-11
06976143660057Juneland0052023-04-11
06976143660064Juneland0062023-04-11
06976143660071Juneland0072023-04-11
06976143660088Juneland0082023-04-11
06976143660095Juneland0092023-04-11
06976143660101Juneland0102023-04-11
06976143660118Juneland0112023-04-11
06976143660125Juneland0122023-04-11
06976143660019Juneland0012023-04-07
06976143660033Juneland0032023-04-07
06976143660002Juneland0002023-03-23

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