AccessGUDID - DEVICE: Monosof (10884521215856)

GUDID

Device Identifier (DI) Information

Brand Name: Monosof
Version or Model: SN5862GMDL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SN5862GMDL
Company Name: Covidien LP

Primary DI Number: 10884521215856
Issuing Agency: GS1
Commercial Distribution End Date: October 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Monofilament Nylon, P-14, 1 Black Strand

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?
38000	Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAR	Suture, nonabsorbable, synthetic, polyamide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K900531	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
Special Storage Condition, Specify: No;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter, 4/0, N/A;
Length: 18 Inch

Device Record Status

Public Device Record Key: 9f546121-85e9-4a43-8d30-65e288784bda
Public Version Date: June 24, 2025
Public Version Number: 8
DI Record Publish Date: May 28, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521215853	12	10884521215856	2019-10-02	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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