AccessGUDID - DEVICE: HEARTLINE RING TIP FORCEPS (B099280078290)

GUDID

Device Identifier (DI) Information

Brand Name: HEARTLINE RING TIP FORCEPS
Version or Model: 2800-7829
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B099280078290
Issuing Agency: HIBCC
Commercial Distribution End Date: June 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: HEARTLINE RING TIP FORCEPS TYING PLATFORM TUNGSTEN CARBIDE DUST STRAIGHT 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?
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. 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: 22.7 Centimeter
Device Size Text, specify: 5mm Diameter Shaft
Device Size Text, specify: 1mm Tip

Device Record Status

Public Device Record Key: c729eabb-0a1d-49ed-b098-c199403f71f1
Public Version Date: July 06, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016