FDA UDI
In Commercial Distribution
🇺🇸 United States
THD BIOPSY
DI: 08051887049851
·
Model: THD BIOPSY (J)
·
THD SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- THD BIOPSY
- Primary DI
- 08051887049851
- Version / Model
- THD BIOPSY (J)
- Catalog Number
- 800317
- Company Name
- THD SPA
- Labeler DUNS
- 338430324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- 22ad5873-1d7a-41ac-a64a-0624a56250d5
Device Description
THD BIOPSY are disposable rigid biopsy forceps for use with THD anoscopes and rectoscopes during various diagnostic and surgical procedures of the anal canal and/or rectum. THD BIOPSY are equipped with a rotating ring nut that allows the instrument to be rotated and oriented during the procedure, facilitating the access from different angles.
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
- 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 |
|---|---|---|---|---|
| 46228 | Rigid endoscopic biopsy forceps, single-use | A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with 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 | 18051887049865 | GS1 | CARTON BOX | 10 | In Commercial Distribution | |
| Primary | 08051887049851 | GS1 | ||||
| Previous | 08051887045754 | GS1 |
Customer Contacts
- Phone
- +390522634311
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18 | Centimeter |