FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioteque America, Inc.
DI: 00810142352338
·
Model: BA8200
·
Bioteque America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bioteque America, Inc.
- Primary DI
- 00810142352338
- Version / Model
- BA8200
- Company Name
- Bioteque America, Inc.
- Labeler DUNS
- 785179719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-08
- Public Version
- 1
- Public Version Date
- 2025-05-16
- Public Version Status
- New
- Public Device Record Key
- 625ebefc-8f19-4a0b-a4f3-c62a39da7f9b
Device Description
Preferred Curette Sureflex
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | Obstetrics/Gynecology | 884.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11531 | Endometrial biopsy kit | A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810142352369 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00810142352338 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020628 | 000 |