AccessGUDID - DEVICE: EXMOOR (05060180251949)

GUDID

Device Identifier (DI) Information

Brand Name: EXMOOR
Version or Model: E.401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E401
Company Name: EXMOOR PLASTICS LIMITED

Primary DI Number: 05060180251949
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 298725490 *Terms of Use

Device Description: Bone Pate 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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep out of direct sunlight.
Special Storage Condition, Specify: Store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c29dd10-e1b6-4ce0-897a-f6f827327e56
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: September 20, 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441823351040
Email: sales@exmoorltd.com

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