AccessGUDID - DEVICE: NA (00085412000084)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 2B8045
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2B8045
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412000084
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2022
Device Count: 1000
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Small Hand Sealer Clips

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?
62454	Medical tubing clip/clamp, permanent	A non-sterile, small, metallic or plastic, clip-like device designed to irreversibly (permanently) compress a piece of medical device tubing to occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It is intended to be compressed onto the tubing and retain its compressed form. It may be referred to as a clip or a clamp. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING

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: 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: 1e81bff3-79bf-4200-b593-a0e9f3d6216e
Public Version Date: July 21, 2023
Public Version Number: 9
DI Record Publish Date: January 13, 2017