AccessGUDID - DEVICE: KangLi Locking Plates System (06937762166481)

GUDID

Device Identifier (DI) Information

Brand Name: KangLi Locking Plates System
Version or Model: T4071007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T4071007
Company Name: Suzhou Kangli Orthopaedics Instrument Co.,Ltd.

Primary DI Number: 06937762166481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 527054774 *Terms of Use

Device Description: Tibial Locking Plates 7 holes

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):	No
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?
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133840	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 143 Millimeter
Device Size Text, specify: Holes: 7 holes

Device Record Status

Public Device Record Key: eb798a63-9391-451a-a4e2-3452b50aaeea
Public Version Date: September 11, 2024
Public Version Number: 7
DI Record Publish Date: September 03, 2016