AccessGUDID - DEVICE: Dilator w/Cannula (06938695537676)

GUDID

Device Identifier (DI) Information

Brand Name: Dilator w/Cannula
Version or Model: FG2410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG2410
Company Name: Shanghai Kinetic Medical Co., Ltd.

Primary DI Number: 06938695537676
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 528198569 *Terms of Use

Device Description: Dilator w/Cannula, 8G (4.2mm)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60748	Periodontal disease-associated bacteria/genetic risk factor IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from 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 nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Porphyromonas, Prevotella, Tannerella, Actinobacillus and/or Treponema species.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
NDN	Cement, Bone, Vertebroplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113742	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.2 Millimeter

Device Record Status

Public Device Record Key: 684eeef0-52d9-4300-b1b0-f9d29c057ae7
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: May 31, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +862150720558
Email: qingmeiwei@shkmc.com.cn

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