AccessGUDID - DEVICE: KMC Double Balloon Assembly, 8 Gauge, 15mm (06938695546494)

GUDID

Device Identifier (DI) Information

Brand Name: KMC Double Balloon Assembly, 8 Gauge, 15mm
Version or Model: KMCA-100-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai Kinetic Medical Co., Ltd.

Primary DI Number: 06938695546494
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 528198569 *Terms of Use

Device Description: KMC Double Balloon Assembly, 8 Gauge, 15mm

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:	Yes
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?
47129	Balloon kyphoplasty kit	A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.	Active	false

FDA Product Code

[?]

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

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
Balloon Length: 15 Millimeter
Needle Gauge: 8 Gauge

Device Record Status

Public Device Record Key: 311ed2ba-51ca-4701-b155-9330cf7ac614
Public Version Date: October 09, 2020
Public Version Number: 1
DI Record Publish Date: October 01, 2020