AccessGUDID - DEVICE: E.M Adams co, inc. (18100013402095)

GUDID

Device Identifier (DI) Information

Brand Name: E.M Adams co, inc.
Version or Model: 14-3369-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: E.M. ADAMS, INC.

Primary DI Number: 18100013402095
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 001403807 *Terms of Use

Device Description: SINGLE INSTRUMENT

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
58949	General-purpose surgical scissors, single-use	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K812133	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5" X 9" POUCH/WIRE CUTTER SCISSORS, STRAIGHT

Device Record Status

Public Device Record Key: 099fb27f-419d-46b1-bcf2-59c4b958adb7
Public Version Date: September 23, 2022
Public Version Number: 4
DI Record Publish Date: December 31, 2019