DEVICE: NA (07613327064247)
Device Identifier (DI) Information
NA
0505880115
In Commercial Distribution
0505880115
STRYKER CORPORATION
0505880115
In Commercial Distribution
0505880115
STRYKER CORPORATION
5.0 Fr., Biopsy Cup Forcep, Flexible
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 17633 | Urethrotome |
A surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HIH | HYSTEROSCOPE (AND ACCESSORIES) |
| FAJ | Cystoscope and accessories, flexible/rigid |
| FAS | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| KQT | EVACUATOR, GASTRO-UROLOGY |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| Ethylene Oxide |
| Hydrogen Peroxide |
| Moist Heat or Steam Sterilization |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
0785b231-1b1d-44bc-a19f-f79abbdda19c
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)624-4422
xx@xx.xx
xx@xx.xx