AccessGUDID - DEVICE: “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) (04719878787116)

GUDID

Device Identifier (DI) Information

Brand Name: “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
Version or Model: TR2-3300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR2-3300
Company Name: Paonan Biotech Co.,Ltd.

Primary DI Number: 04719878787116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657397790 *Terms of Use

Device Description: T2 Long Arm Breaker

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:	No
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?
64479	Surgical implant handling forceps	A hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 1430499f-7479-4d7a-b2c7-6723a55d7589
Public Version Date: April 23, 2024
Public Version Number: 1
DI Record Publish Date: April 15, 2024