AccessGUDID - DEVICE: TEKTONA HV US Bone Cement (08031497003351)

GUDID

Device Identifier (DI) Information

Brand Name: TEKTONA HV US Bone Cement
Version or Model: TEK-BC HV US-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECRES SPA

Primary DI Number: 08031497003351
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435428396 *Terms of Use

Device Description: TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. TEKTONA HV US Bone Cement is a closed sysyem which containes the powder and liquid components separately. The device is disposable and sterile.

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?
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDN	Cement, Bone, Vertebroplasty
LOD	Bone Cement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122175	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78082db7-c814-44ea-8379-c793da2dca97
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023