FDA UDI
In Commercial Distribution
🇺🇸 United States
MICASEPT BIOPSY / SCISSOR FORCEPS
DI: 00192896008724
·
Model: 20934-03
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICASEPT BIOPSY / SCISSOR FORCEPS
- Primary DI
- 00192896008724
- Version / Model
- 20934-03
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 2
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- 1a8470e4-de98-4416-a488-58179de91e8e
Device Description
MICASEPT CIRADUR PE-FORCEPS POINTED CURVED DOWN
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35286 | Biopsy punch, reusable | A manual surgical instrument designed to obtain a tissue or bone sample typically for histopathological analysis. The instrument may be ring-handled, pistol grip, or shaft-like in design. Ring-handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B09920934030 | HIBCC | ||||
| Primary | 00192896008724 | GS1 |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 300 | Millimeter | |
| Device Size Text, specify | 30° Jaw | ||
| Device Size Text, specify | 4.5mm Diameter |