AccessGUDID - DEVICE: Signia (10884521845497)

GUDID

Device Identifier (DI) Information

Brand Name: Signia
Version or Model: SIGCIRXL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521845497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: SIGNIA CIRCULAR ADAPTER XL LENGTH FT

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):	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?
62384	Endoscopic cutting stapler connector, electronic-sensing	A rod-like component of an endoscopic cutting stapler with electronic sensors intended to enable connection between the stapler handpiece and the endpiece/loading unit with dimensions (width) compatible with endoscopic access, but may not preclude open surgical use. It is a thin metal housing that contains motor mating connectors and electronic communication interfaces. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAG	Stapler, surgical
GDW	Staple, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240881	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 55 and 101 KiloPascal
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 55 and 101 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Length: 30 Centimeter
Device Size Text, specify: XL;

Device Record Status

Public Device Record Key: 38367a4e-ebd7-4054-8e74-004e86ab8106
Public Version Date: January 28, 2025
Public Version Number: 2
DI Record Publish Date: November 29, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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