FDA UDI
In Commercial Distribution
🇺🇸 United States
Circular Sizer
DI: 20705036015427
·
Model: CS23
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Circular Sizer
- Primary DI
- 20705036015427
- Version / Model
- CS23
- Catalog Number
- CS23
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-16
- Public Version
- 1
- Public Version Date
- 2019-07-24
- Public Version Status
- New
- Public Device Record Key
- 0123ebb1-855c-405f-80b8-cf2894859b08
Device Description
The Circular Sizer is a non-sterile, stainless steel device sized 23 mm to correspond with the head sizes of ETHICON Circular Staplers (Intraluminal Staplers).
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58016 | Colorectal sizer | A hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection. It is typically made of high-grade stainless steel and consists of a shaft handle at the proximal end and an oval-shaped head at the distal end that is introduced transanally. The device is typically available in a set of graduated sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 10705036015420 | GS1 | ||||
| Package | 30705036015424 | GS1 | CASE | 16 | In Commercial Distribution | |
| Primary | 20705036015427 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]