AccessGUDID - DEVICE: Snare X5 (17290015518083)

GUDID

Device Identifier (DI) Information

Brand Name: Snare X5
Version or Model: MT-FA09
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDI-TATE LTD

Primary DI Number: 17290015518083
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 532003626 *Terms of Use

Device Description: Pack of 5 individually packed Snare

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):	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?
63402	Bare-metal urethral stent, short-term	A sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is made entirely of metal [e.g., nickel-titanium alloy (Nitinol)] and is typically self-expanded in situ; disposable devices intended to assist implantation or removal (e.g., attached thread) may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKA	Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190020	000

Device Exempt from Premarket Submission: No 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: 66846eb7-3168-412b-b967-fb1046e8d23d
Public Version Date: May 09, 2022
Public Version Number: 2
DI Record Publish Date: July 20, 2021

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

[?]

No Customer Contact currently defined

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