FDA UDI
In Commercial Distribution
🇺🇸 United States
Optimos™ Biopsy Forceps
DI: 08809909417108
·
Model: BF160C
·
TAEWOONGMEDICAL.CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Optimos™ Biopsy Forceps
- Primary DI
- 08809909417108
- Version / Model
- BF160C
- Catalog Number
- BF160C
- Company Name
- TAEWOONGMEDICAL.CO.,LTD
- Labeler DUNS
- 689484322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-09
- Public Version
- 1
- Public Version Date
- 2025-01-17
- Public Version Status
- New
- Public Device Record Key
- 33aa5c3b-3273-4459-9f26-0b8d14a89e3e
Device Description
The Optimos™ Biopsy Forceps is used endoscopically to biopsy tissue specimens throughout the alimentary tract for histologic examination.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | 876.1075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38711 | Flexible endoscopic biopsy forceps, single-use | A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08809909417382 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 08809909417108 | GS1 |
Customer Contacts
- Phone
- 323-692-0028
- [email protected]
- Phone
- +82319960641
- [email protected]