| Primary Device ID | 10705036015437 |
| NIH Device Record Key | 0fda8f51-cf0e-4a24-be45-9cc2a510b1b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Circular Sizer |
| Version Model Number | CS31 |
| Catalog Number | CS31 |
| Company DUNS | 044606982 |
| Company Name | ETHICON ENDO-SURGERY, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(877)384-4266 |
| customersupport@eesus.jnj.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705036015437 [Direct Marking] |
| GS1 | 20705036015434 [Primary] |
| GS1 | 30705036015431 [Package] Contains: 20705036015434 Package: CASE [16 Units] In Commercial Distribution |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705036015437]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-24 |
| Device Publish Date | 2019-07-16 |
| 10705036015437 | The Circular Sizer is a non-sterile, stainless steel device sized 31 mm to correspond with the h |
| 10705036015420 | The Circular Sizer is a non-sterile, stainless steel device sized 23 mm to correspond with the h |