AccessGUDID - DEVICE: Arthrex® (00888867040397)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-6569
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR-6569
Company Name: ARTHREX, INC.

Primary DI Number: 00888867040397
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: EXPANULA WITH NO-SQUIRT CAP

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?
62456	Arthroscopic access cannula seal, single-use	A small, sterile device intended to create a seal between an arthroscopic access cannula (not included) and an appropriately sized arthroscopic instrument, to inhibit the leakage of flushing media (e.g., NaCl solution) during an arthroscopic procedure. It is intended to be fitted directly onto the proximal end of the cannula and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBH	Accessories, arthroscopic

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
No Device Sizes

Device Record Status

Public Device Record Key: 2f3646b1-b2d8-402e-9545-2c6d65f2cfeb
Public Version Date: May 01, 2019
Public Version Number: 2
DI Record Publish Date: October 04, 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
10888867040394	5	00888867040397		In Commercial Distribution	Box

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(800)934-4404
Email: complaints@arthrex.com

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