AccessGUDID - DEVICE: Extended Tip Applicator (10884521171367)

GUDID

Device Identifier (DI) Information

Brand Name: Extended Tip Applicator
Version or Model: 205208
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521171367
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Single Use Applicator

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?
58780	Open-surgery adhesive/sealant applicator, single-channel	A sterile applicator designed for the controlled application of a surgical adhesive/sealant during open surgery (e.g., laparotomy, vascular surgery) for various haemostatic and/or tissue bonding uses. It typically consists of an applicator (e.g., dropper, spreader) for use with a single-component syringe; it may include the syringe and additional devices to assist extraction of the adhesive/sealant from a bottle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Length: 8 Centimeter

Device Record Status

Public Device Record Key: cc130850-adba-4fb2-92ef-58b5426c7437
Public Version Date: June 13, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016