FDA UDI
In Commercial Distribution
🇺🇸 United States
SCANLAN®
DI: 00846159021301
·
Model: 9009-718SC
·
SCANLAN INTERNATIONAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCANLAN®
- Primary DI
- 00846159021301
- Version / Model
- 9009-718SC
- Catalog Number
- 9009-718SC
- Company Name
- SCANLAN INTERNATIONAL INC
- Labeler DUNS
- 023055619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-05
- Public Version
- 4
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- 626cdf71-2ef8-410f-870a-d28ac72408f1
Device Description
Endoscopic Micro Scissors
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35080 | Rigid endoscopic tissue manipulation forceps, reusable | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846159021301 | GS1 |
Customer Contacts
- Phone
- 651-298-0997
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945474 | 000 |