AccessGUDID - DEVICE: Premium Multifire TA (10884521045965)

GUDID

Device Identifier (DI) Information

Brand Name: Premium Multifire TA
Version or Model: 010315
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 010315
Company Name: Covidien LP

Primary DI Number: 10884521045965
Issuing Agency: GS1
Commercial Distribution End Date: September 03, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Vascular Stapler

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?
59873	Open-surgery manual linear stapler, single-use	A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHM	APPARATUS, SUTURING, STOMACH AND INTESTINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801589	000

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
Handling Environment Temperature: less than 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 30 Millimeter
Device Size Text, specify: Height,V3,N/A;

Device Record Status

Public Device Record Key: 4f158036-0f17-4158-9b80-44c73125006e
Public Version Date: June 24, 2025
Public Version Number: 4
DI Record Publish Date: August 10, 2018