Primary Device ID | 00878953007656 |
NIH Device Record Key | 8960d4ed-5fd0-4d64-9817-d2e9ed2a3489 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Video Camera Insert |
Version Model Number | 0010-0728 |
Company DUNS | 796308653 |
Company Name | AMERICAN MEDICAL SYSTEMS |
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 | false |
Serial Number | true |
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 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00878953007656 [Primary] |
FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-02-13 |
Device Publish Date | 2018-10-03 |
00878953004822 - SureFlex 200 | 2019-04-25 200 Lithotripsy Fiber |
00878953000015 - AddStat | 2019-02-13 |
00878953000046 - EndoStat | 2019-02-13 0.2mm 12ft |
00878953000053 - EndoStat | 2019-02-13 0.2mm 12ft SL |
00878953000060 - EndoStat | 2019-02-13 0.3mm 12ft |
00878953000077 - EndoStat | 2019-02-13 0.6mm 12ft |
00878953000084 - EndoStat | 2019-02-13 0.6mm 18ft |
00878953000091 - EndoStat | 2019-02-13 0.6mm 12ft |