FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioteque Taiwan Ltd.
DI: 04719894433424
·
Model: WC-400MM
·
Bioteque Taiwan Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bioteque Taiwan Ltd.
- Primary DI
- 04719894433424
- Version / Model
- WC-400MM
- Company Name
- Bioteque Taiwan Ltd.
- Labeler DUNS
- 657769858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-10
- Public Version
- 1
- Public Version Date
- 2025-03-18
- Public Version Status
- New
- Public Device Record Key
- 99aa35f8-b486-4c7d-8062-0f07a24d8b53
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719894433424 | GS1 | ||||
| Package | 04719894433431 | GS1 | bag | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130087 | 000 |