AccessGUDID - DEVICE: Arthrex® (00888867362192)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-1090NH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR-1090NH
Company Name: ARTHREX, INC.

Primary DI Number: 00888867362192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: NanoGrip, NanoScope Optics 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:	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?
65126	Surgical instrument handle grip	A device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). 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: 577d5670-d03e-4478-b5de-7bdd45064a9a
Public Version Date: November 17, 2023
Public Version Number: 3
DI Record Publish Date: October 30, 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
10888867362199	5	00888867362192		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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