AccessGUDID - DEVICE: Scanlan® VASCU-STATT® approximator single-use bulldog clamp (00846159000528)

GUDID

Device Identifier (DI) Information

Brand Name: Scanlan® VASCU-STATT® approximator single-use bulldog clamp
Version or Model: 1001-509
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001-509
Company Name: SCANLAN INTERNATIONAL INC

Primary DI Number: 00846159000528
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023055619 *Terms of Use

Device Description: Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (white), clamping pressure 25-30 g (1/sterile pkg)

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):	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?
62480	Surgical bulldog clamp, single-use	A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

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: 28f33075-e127-40dc-b3d5-e904f9fd0314
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: July 14, 2017