AccessGUDID - DEVICE: Bioteque Taiwan Ltd. (04719894433424)

GUDID

Device Identifier (DI) Information

Brand Name: Bioteque Taiwan Ltd.
Version or Model: WC-400MM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bioteque Taiwan Ltd.

Primary DI Number: 04719894433424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657769858 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
10695	Bartholin's gland catheter	A short (e.g., 5 cm) plastic tube designed to form a tract from either of the two small reddish glands (Bartholin's glands), one on each side of the vaginal orifice, to the space where the urethra and the vagina open (vaginal vestibulum). It may include a balloon at the tip to ensure retention within the gland. The device is typically used for drainage in the treatment of Bartholin's gland cysts and abscesses. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130087	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: 99aa35f8-b486-4c7d-8062-0f07a24d8b53
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04719894433431	6	04719894433424		In Commercial Distribution	bag

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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