FDA UDI
In Commercial Distribution
🇺🇸 United States
Tube Cutter
DI: EBESCK10220
·
Model: CK1022
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tube Cutter
- Primary DI
- EBESCK10220
- Version / Model
- CK1022
- Catalog Number
- CK1022
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 3
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- c1e520b6-6373-464a-951d-b5f27a1b44a9
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FNS | Ring Cutter | General Hospital | 880.6200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46531 | Paper/plastic sheet guillotine | A manually-operated cutting device designed to cut or trim sheets of paper or thin plastic (e.g., transparency film, or x-ray film) into a desired size. It is typically made up of a metal frame on a base that has a pivoted cutting blade with a handle that is attached and operated by the user. Moving the handle/blade in a downward movement, this cuts the object(s) that have been placed on the base as it passes a stationary blade that is fastened to the base. It is made of plastic and metal, high-grade stainless steel for the blades, and is available in various shapes and sizes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBESCK10220 | HIBCC | ||||
| Package | EBESCK10221 | HIBCC | Carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry