AccessGUDID - DEVICE: Swann Morton Ltd. (05033955019600)

GUDID

Device Identifier (DI) Information

Brand Name: Swann Morton Ltd.
Version or Model: BULK No. 3 STAINLESS STITCH CUTTERS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1960
Company Name: SWANN-MORTON LIMITED

Primary DI Number: 05033955019600
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 212397483 *Terms of Use

Device Description: Suture cutter. A dedicated hand held surgical instrument used for cutting sutures. It will typically have a protected scalpel like blade which may be fixed or have a scissor cutting action.

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?
16224	Suture cutter, reusable	A dedicated hand-held surgical instrument designed for cutting sutures. It will typically have a protected scalpel-like blade which may be fixed or have a scissors-like cutting action. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZT	Cutter, Surgical

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: 03980090-d6a5-4f95-8386-c314cd57711e
Public Version Date: May 16, 2022
Public Version Number: 1
DI Record Publish Date: May 06, 2022