AccessGUDID - DEVICE: HEARTLINE RYDER NEEDLE HOLDER (B0992800020S0)

GUDID

Device Identifier (DI) Information

Brand Name: HEARTLINE RYDER NEEDLE HOLDER
Version or Model: 2800-020S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B0992800020S0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE JAW SQUEEZE HANDLE

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):	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?
12726	Suturing needle holder, reusable	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152400	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 17 Centimeter
Device Size Text, specify: 5mm Shaft

Device Record Status

Public Device Record Key: e0ea6494-9a66-49f8-933c-b4eee99a6b5d
Public Version Date: January 08, 2021
Public Version Number: 9
DI Record Publish Date: August 19, 2016