AccessGUDID - DEVICE: COX BONE DUST COLLECTOR (00850000126060)

GUDID

Device Identifier (DI) Information

Brand Name: COX BONE DUST COLLECTOR
Version or Model: S-3500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oto-Med, Inc.

Primary DI Number: 00850000126060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059817742 *Terms of Use

Device Description: COX BONE DUST COLLECTOR

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?
44819	Otological bone particle collector	A filtering device designed to be placed into an otological surgical suction line to collect bone fragments. It consists of a filter within a housing and is intended to save bone particles during the first stage of middle ear surgery for future use. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXP	Bone Particle Collector

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: 7486fb60-05f8-456e-ad56-dcc1ec13eb1a
Public Version Date: December 21, 2020
Public Version Number: 2
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: Yes
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(866)472-2363
Email: info@gracemedical.com

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