FDA UDI
In Commercial Distribution
🇺🇸 United States
CROWN SURGICAL
DI: B92402447DB0
·
Model: FORCEPS
·
CROWN SURGICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- CROWN SURGICAL
- Primary DI
- B92402447DB0
- Version / Model
- FORCEPS
- Catalog Number
- 02-447-DB
- Company Name
- CROWN SURGICAL CORPORATION
- Labeler DUNS
- 645681094
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- f9c750af-2e5a-45a2-8cf6-295823e76370
Device Description
MAGILL Catheter Introducing Forceps, Adult Size, 9-3/4"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62490 | Dressing/utility forceps, scissors-like, single-use | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B92402447DB2 | HIBCC | CARDBOARD BOX | 120 | In Commercial Distribution | |
| Primary | B92402447DB0 | HIBCC | ||||
| Unit of Use | B92402447DB1 | HIBCC |
Customer Contacts
- Phone
- 15162927400
- [email protected]