AccessGUDID - DEVICE: ClosureFast (10884521140172)

GUDID

Device Identifier (DI) Information

Brand Name: ClosureFast
Version or Model: AN-19G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521140172
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Arterial Needle,Ultra Thin Wall,19 G (1.067 mm) x 2.75"" (70 mm)

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":	Yes
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?
12747	Intra-arterial needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to puncture an artery. The needle may be heparinized to prevent blood clotting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDF	GUIDE, NEEDLE, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Length: 2.75 Inch

Device Record Status

Public Device Record Key: a27e1c33-0020-4b39-82d7-15944c1682bf
Public Version Date: June 24, 2025
Public Version Number: 4
DI Record Publish Date: October 13, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521140179	50	10884521140172		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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