AccessGUDID - DEVICE: MICRO-LINE (04038653074280)

GUDID

Device Identifier (DI) Information

Brand Name: MICRO-LINE
Version or Model: GD306R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GD306R
Company Name: Aesculap AG

Primary DI Number: 04038653074280
Issuing Agency: GS1
Commercial Distribution End Date: November 18, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: MICRO-LINE SPRAY NOZZLE F/GD305

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?
18033	Surgical mist irrigation tip	A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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: b1c82a7f-dcd6-42af-b77d-2dba7c0c1786
Public Version Date: January 19, 2022
Public Version Number: 4
DI Record Publish Date: June 07, 2016

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)282-9000
Email: GUDID.BBMUS_Service@bbraun.com

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