AccessGUDID - DEVICE: GYNECARE TVT (10705031062245)

GUDID

Device Identifier (DI) Information

Brand Name: GYNECARE TVT
Version or Model: 810061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 810061
Company Name: Ethicon Sàrl

Primary DI Number: 10705031062245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480920383 *Terms of Use

Device Description: Reusable Rigid Catheter Guide

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
63569	Urethral manipulator	A non-sterile, hand-held, rigid, stylet-like rod designed to be inserted into the lumen of an in situ urological catheter (not included) to facilitate lateral manipulation of the urethra/bladder during surgical intervention (e.g., female stress urinary incontinence surgical mesh implantation), typically to avoid trauma to the urethra/bladder. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 2835edad-a53d-41df-80f3-f8ac8a8a3247
Public Version Date: August 25, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2015

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(877)384-4266
Email: xxx@xxx.xxx

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