FDA.reportPublic FDA data

Dilator w/Cannula

Primary DI
06938695537676
Brand
Dilator w/Cannula
Company
Shanghai Kinetic Medical Co., Ltd.
Model
FG2410
Catalog number
FG2410
Device description
Dilator w/Cannula, 8G (4.2mm)
Published
2020-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113742000KMC KYPHOPLASTY SYSTEMShanghai Kinetic Medical Co., Ltd.2012-09-17NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938695537676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938695537676069386955376766938695537676

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal disease-associated bacteria/genetic risk factor IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple bacteria associated with periodontal disease, and for determining the genetic risk for developing periodontal disease based on detection of gene fragments coding for interleukin-1-alpha and interleukin-1-beta, and the DRB1*04 gene coding for HLA-DR4 in a clinical specimen, using a multiplex method. Organisms detected may include (but are not limited to) Porphyromonas, Prevotella, Tannerella, Actinobacillus and/or Treponema species.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+862150720558qingmeiwei@shkmc.com.cn

Regulatory Flags#

DUNS number
528198569
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938695502155Bone DrillFG27012025-12-09
06938695502254CannulaFG22032025-12-09
06938695521026DrillFG21002025-12-09
06938695527004Bone DrillFG27002025-12-09
06938695522009CannulaFG2200FG22002016-12-05
06938695524003DilatorFG2400FG24002016-12-05
06938695530066Puncture NeedleFG3006FG30062016-05-26
06938695546067KMC Guide Wire, 1.6mm, Blunt TipKMC-000-002020-10-01
06938695546074KMC Guide Wire, 1.6mm, Sharp TipKMC-000-102020-10-01
06938695546081KMC Access Needle, 11 Gauge, 95mm, Bevel TipKMC-001-002020-10-01
06938695546098KMC Access Needle, 11 Gauge, 95mm, Pyramid TipKMC-001-102020-10-01
06938695546104KMC Access Needle, 11 Gauge, 115mm, Pyramid TipKMC-001-112020-10-01
06938695546111KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond TipKMC-001-202020-10-01
06938695546128KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel TipKMC-001-302020-10-01
06938695546135KMC Access Needle, 13 Gauge, 95mm, Pyramid TipKMC-002-002020-10-01
06938695546142KMC Access Needle, 13 Gauge, 115mm, Pyramid TipKMC-002-012020-10-01
06938695546159KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel TipKMC-002-102020-10-01
06938695546166KMC Balloon Catheter, 8 Gauge, 10mmKMC-003-102020-10-01
06938695546173KMC Balloon Catheter, 8 Gauge, 15mmKMC-003-152020-10-01
06938695546180KMC Balloon Catheter, 8 Gauge, 20mmKMC-003-202020-10-01

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