FDA UDI
In Commercial Distribution
🇺🇸 United States
ConMed
DI: B504TCOC46010
·
Model: OC4601
·
Provision
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ConMed
- Primary DI
- B504TCOC46010
- Version / Model
- OC4601
- Company Name
- Provision
- Labeler DUNS
- 016889401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-15
- Public Version
- 1
- Public Version Date
- 2024-01-23
- Public Version Status
- New
- Public Device Record Key
- 530b4218-ba26-4cda-a54a-8793c198b0d6
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
- Yes
- 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 |
|---|---|---|---|---|
| NBH | Accessories, Arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61613 | Endoscopic electrosurgical mucosal biopsy/resection set | A collection of devices designed to be used during an endoscopic mucosal tissue biopsy and/or therapeutic resection procedure to: 1) isolate a specified section of mucosa using endoscopic suction and application of ligature bands; and 2) resect the lesion using monopolar electrosurgical energy. It consists of a ligation unit with distally-mounted bands and a flexible electrosurgical snare. Suction is applied to retract the tissue into the ligator cap, the ligature band(s) are then deployed, followed by electrosurgical resection of the tissue with the snare. Disposable devices for histological sample processing (e.g., biowraps) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B504TCOC46010 | HIBCC |
Customer Contacts
- Phone
- 541-480-7953
- [email protected]