AccessGUDID - DEVICE: Topical Skin Adhesive (10884521806191)

GUDID

Device Identifier (DI) Information

Brand Name: Topical Skin Adhesive
Version or Model: LXS6M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521806191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: TOPICAL SKIN ADHESIVE LXS6M XS

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?
34164	Skin-approximation adhesive	A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPN	Tissue adhesive for the topical approximation of skin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151182	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
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.4 mL;

Device Record Status

Public Device Record Key: cd670d68-fb77-44dc-bb51-df7a1cf6bdd3
Public Version Date: June 13, 2025
Public Version Number: 5
DI Record Publish Date: November 26, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521806198	6	10884521806191		In Commercial Distribution	PACK_OR_INNER_PACK

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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