AccessGUDID - DEVICE: DFS (10884521080744)

GUDID

Device Identifier (DI) Information

Brand Name: DFS
Version or Model: 070614
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 070614
Company Name: Covidien LP

Primary DI Number: 10884521080744
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: Fascia Stapler

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
GDW	STAPLE, IMPLANTABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780695	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Width,N/A,N/A;

Device Record Status

Public Device Record Key: 70147d08-d837-45e9-a90c-b85767a8d221
Public Version Date: June 24, 2025
Public Version Number: 7
DI Record Publish Date: August 28, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521080741	6	10884521080744	2020-09-03	Not in Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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