AccessGUDID - DEVICE: Arthrex® (00888867446144)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-3375-4212
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR-3375-4212
Company Name: ARTHREX, INC.

Primary DI Number: 00888867446144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: TROCAR FOR HF PANO SHTH,w/handle

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?
61424	Laparoscopic trocar blade, reusable	A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 21a4499d-baca-464e-99ca-b24eaf997055
Public Version Date: June 17, 2024
Public Version Number: 1
DI Record Publish Date: June 07, 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)934-4404
Email: complaints@arthrex.com

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