AccessGUDID - DEVICE: Richard-Allan® Tonsil Snare (00887761005587)

GUDID

Device Identifier (DI) Information

Brand Name: Richard-Allan® Tonsil Snare
Version or Model: 2408
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00887761005587
Issuing Agency: GS1
Commercial Distribution End Date: June 16, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Snares are intended to be used with snare gun for removal of tonsil and nasal polyps.

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:	Yes
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?
13632	Tonsil snare	A manual surgical instrument inserted into the oral cavity to remove the tonsils during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the root of the tonsil to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBZ	SNARE, TONSIL

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 029d6c0e-2a09-485d-86ea-94184e09f3ab
Public Version Date: November 13, 2023
Public Version Number: 4
DI Record Publish Date: December 06, 2018