AccessGUDID - DEVICE: Arthrex® (00888867004115)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-1204AF-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR-1204AF-100
Company Name: ARTHREX, INC.

Primary DI Number: 00888867004115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: 10.0 MM FLIP CUTTER II

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?
64994	Reverse bone-resection orthopaedic reamer	An orthopaedic surgical instrument in the form of a shaft with a flip-out orthogonal cutting spike intended to resect bone (cut out part of the bone) as it is withdrawn to create a cylindrical recess for the acceptance of a prosthetic implant, typically a prosthetic ligament. It is introduced percutaneously through the bone shaft, and when in place the cutting spike is extended so that bone can be resected as the tip is rotated and withdrawn from the bone. It is made of metal and may be supplied with additional tools to assist with use (e.g., guide, depth guide). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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: 4ae3146f-cc0d-4cd5-b3bf-195c5f024504
Public Version Date: July 24, 2020
Public Version Number: 5
DI Record Publish Date: September 21, 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
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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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