AccessGUDID - DEVICE: MICASEPT KELLY FORCEPS (B09920921290)

GUDID

Device Identifier (DI) Information

Brand Name: MICASEPT KELLY FORCEPS
Version or Model: 20921-29
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09920921290
Issuing Agency: HIBCC
Commercial Distribution End Date: September 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: MICASEPT KELLY FORCEPS WITHOUT RATCHET CURVED DOWN

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?
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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 [?]
K002877	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
Device Size Text, specify: 4.5mm Diameter
Device Size Text, specify: 30° Jaw
Length: 300 Millimeter

Device Record Status

Public Device Record Key: 0a48f20f-ca0e-47be-9a34-5b253d781153
Public Version Date: August 21, 2019
Public Version Number: 9
DI Record Publish Date: September 28, 2016