FDA.report

Juneland

Primary DI
06976143660071
Brand
Juneland
Company
Suzhou Juneland Medical Co., Ltd.
Model
007
Device description
implant kit II
Published
2023-04-11
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
KDDKit, Surgical Instrument, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976143660071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976143660071069761436600716976143660071

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
06976143660088Juneland0082023-04-11
06976143660095Juneland0092023-04-11
06976143660101Juneland0102023-04-11
06976143660118Juneland0112023-04-11
06976143660125Juneland0122023-04-11
06976143660019Juneland0012023-04-07
06976143660026Juneland0022023-04-07
06976143660033Juneland0032023-04-07
06976143660002Juneland0002023-03-23

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