AccessGUDID - DEVICE: V. Mueller (10885403048968)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: GU3402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GU3402
Company Name: STERIS CORPORATION

Primary DI Number: 10885403048968
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: WIRE MANDRIN 6FR VAN BUREN CURVE OVERALL LENGTH 15-1/2 inches40CM

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?
11704	Filiform urethral bougie	An extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately-threaded urethral catheter. The tip of the device can be bent or contoured to shapes that will facilitate the progression of the device through the stricture; the tip may be bulbous (an olive tip). It is typically made of plastic material [e.g., polyvinyl chloride (PVC)] with a threaded metal section. It may be threaded at the proximal end to enable it to connect to a filiform follower (e.g., a larger diameter bougie). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZB	STYLET FOR CATHETER, GASTRO-UROLOGY

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: c6156ddd-ff91-41f5-88ac-c5402d25f996
Public Version Date: August 19, 2024
Public Version Number: 3
DI Record Publish Date: August 30, 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)548-4873
Email: xx@xx.xx

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