AccessGUDID - DEVICE: ASSI (00841645112983)

GUDID

Device Identifier (DI) Information

Brand Name: ASSI
Version or Model: ASSI.RDSV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION

Primary DI Number: 00841645112983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055870299 *Terms of Use

Device Description: Hand Applied Single Clamp, 2.0-5.0mm Vessel Dia.

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:	No
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?
17675	Vessel approximator	One of a pair or set of surgical instruments used to grasp the torn or resected portions of a vessel to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. The instrument is also used to grasp a vessel, or separated parts of a vessel, to position it in a surgical opening. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRQ	Hemostat

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 [?]
Moist Heat or Steam 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: 00997cef-5d2d-4582-8efb-bb8dd55426c5
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023