AccessGUDID - DEVICE: LARYNGOSCOPY ALLIGATOR FORCEPS (00192896058521)

GUDID

Device Identifier (DI) Information

Brand Name: LARYNGOSCOPY ALLIGATOR FORCEPS
Version or Model: 1301-270
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1301-270
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896058521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: LARYNGOSCOPIC ALLIGATOR FORCEPS CUP-SHAPED TIP STRAIGHT BLADE CONICAL FLEXIBLE TUBE SHAFT

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?
38810	Flexible endoscopic biopsy forceps, reusable	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAE	FORCEPS, ENT

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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.5 Millimeter Cup
Device Size Text, specify: 2 Millimeter Shaft
Length: 9 Inch

Device Record Status

Public Device Record Key: 86768b79-e67b-4478-8065-43505336a82c
Public Version Date: October 11, 2018
Public Version Number: 1
DI Record Publish Date: September 10, 2018