ClearPetra
GUDID 16944932740294
ClearPetra Cystoscope Sheath, 22Fr×21cm
Well Lead Medical Co.,Ltd
Endoscope sheath, single-use| Primary Device ID | 16944932740294 |
| NIH Device Record Key | 2478b144-76a4-4e74-96b4-b153307d03e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearPetra |
| Version Model Number | 90132221 |
| Company DUNS | 544811862 |
| Company Name | Well Lead Medical Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06944932740297 [Primary] |
| GS1 | 16944932740294 [Package] Contains: 06944932740297 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 26944932740291 [Package] Package: Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161110
FDA Product Code
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-14 |
| Device Publish Date | 2020-12-04 |
On-Brand Devices [ClearPetra]
| 16944932740539 | ClearPetra Nephrostomy Sheath, 22Fr×21cm |
| 16944932740522 | ClearPetra Nephrostomy Sheath, 20Fr×21cm |
| 16944932740515 | ClearPetra Nephrostomy Sheath, 18Fr×21cm |
| 16944932740508 | ClearPetra Nephrostomy Sheath, 16Fr×21cm |
| 16944932740492 | ClearPetra Nephrostomy Sheath, 14Fr×21cm |
| 16944932740485 | ClearPetra Nephrostomy Sheath, 12Fr×21cm |
| 16944932740478 | ClearPetra Nephrostomy Sheath, 10Fr×21cm |
| 16944932740461 | ClearPetra Nephrostomy Sheath, 22Fr×17cm |
| 16944932740454 | ClearPetra Nephrostomy Sheath, 20Fr×17cm |
| 16944932740447 | ClearPetra Nephrostomy Sheath, 18Fr×17cm |
| 16944932740430 | ClearPetra Nephrostomy Sheath, 16Fr×17cm |
| 16944932740423 | ClearPetra Nephrostomy Sheath, 14Fr×17cm |
| 16944932740416 | ClearPetra Nephrostomy Sheath, 12Fr×17cm |
| 16944932740409 | ClearPetra Nephrostomy Sheath, 10Fr×17cm |
| 16944932740393 | ClearPetra Nephrostomy Sheath, 22Fr×13cm |
| 16944932740386 | ClearPetra Nephrostomy Sheath, 20Fr×13cm |
| 16944932740379 | ClearPetra Nephrostomy Sheath, 18Fr×13cm |
| 16944932740362 | ClearPetra Nephrostomy Sheath, 16Fr×13cm |
| 16944932740355 | ClearPetra Nephrostomy Sheath, 14Fr×13cm |
| 16944932740348 | ClearPetra Nephrostomy Sheath, 12Fr×13cm |
| 16944932740331 | ClearPetra Nephrostomy Sheath, 10Fr×13cm |
| 06944932740327 | ClearPetra Cystoscope Sheath, 22Fr×24cm |
| 16944932740317 | ClearPetra Cystoscope Sheath, 20Fr×24cm |
| 16944932740300 | ClearPetra Cystoscope Sheath, 18Fr×24cm |
| 16944932740294 | ClearPetra Cystoscope Sheath, 22Fr×21cm |
| 16944932740287 | ClearPetra Cystoscope Sheath, 20Fr×21cm |
| 16944932740270 | ClearPetra Cystoscope Sheath, 18Fr×21cm |
| 16944932740263 | ClearPetra Ureteral Access Sheath, 14Fr×55cm |
| 16944932740256 | ClearPetra Ureteral Access Sheath, 13Fr×55cm |
| 16944932740249 | ClearPetra Ureteral Access Sheath, 12Fr×55cm |
| 16944932740232 | ClearPetra Ureteral Access Sheath, 11Fr×55cm |
| 16944932740225 | ClearPetra Ureteral Access Sheath, 10Fr×55cm |
| 16944932740218 | ClearPetra Ureteral Access Sheath, 14Fr×46cm |
| 16944932740201 | ClearPetra Ureteral Access Sheath, 13Fr×46cm |
| 16944932740195 | ClearPetra Ureteral Access Sheath, 12Fr×46cm |
| 16944932740188 | ClearPetra Ureteral Access Sheath, 11Fr×46cm |
| 16944932740171 | ClearPetra Ureteral Access Sheath, 10Fr×46cm |
| 16944932740164 | ClearPetra Ureteral Access Sheath, 14Fr×40cm |
| 16944932740157 | ClearPetra Ureteral Access Sheath, 13Fr×40cm |
| 16944932740140 | ClearPetra Ureteral Access Sheath, 12Fr×40cm |
| 16944932740133 | ClearPetra Ureteral Access Sheath, 11Fr×40cm |
| 16944932740126 | ClearPetra Ureteral Access Sheath, 10Fr×40cm |
| 16944932740119 | ClearPetra Ureteral Access Sheath, 14Fr×36cm |
| 16944932740102 | ClearPetra Ureteral Access Sheath, 13Fr×36cm |
| 16944932740096 | ClearPetra Ureteral Access Sheath, 12Fr×36cm |
| 16944932740089 | ClearPetra Ureteral Access Sheath, 11Fr×36cm |
| 16944932740072 | ClearPetra Ureteral Access Sheath, 10Fr×36cm |
| 16944932740065 | ClearPetra Ureteral Access Sheath, 14Fr×26cm |
| 16944932740058 | ClearPetra Ureteral Access Sheath, 13Fr×26cm |
| 16944932740041 | ClearPetra Ureteral Access Sheath, 12Fr×26cm |
Trademark Results [ClearPetra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARPETRA 86970601 5178054 Live/Registered |
WELL LEAD MEDICAL CO., LTD. 2016-04-11 |
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