AccessGUDID - DEVICE: Swann Morton Ltd. (05033955140106)

GUDID

Device Identifier (DI) Information

Brand Name: Swann Morton Ltd.
Version or Model: PARAGON No. 23 NON STERILE DISPOSABLE SCALPELS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PC10
Company Name: SWANN-MORTON LIMITED

Primary DI Number: 05033955140106
Issuing Agency: GS1
Commercial Distribution End Date: April 17, 2024
Device Count: 100
Labeler D-U-N-S® Number*: 212397483 *Terms of Use

Device Description: A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.

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?
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDX	Scalpel, One-Piece

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 [?]
Radiation Sterilization

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: 42520056-a6fe-48ef-b366-34093bdadcc9
Public Version Date: April 18, 2024
Public Version Number: 2
DI Record Publish Date: May 30, 2022