Primary Device ID | 00810045921051 |
NIH Device Record Key | 68285521-458d-4ef9-8d35-2ec8fbe74848 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DuraHand |
Version Model Number | DuraHand |
Catalog Number | DH-350 |
Company DUNS | 041517095 |
Company Name | INSTRUMENT SPECIALISTS, INC. |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810045921051 [Primary] |
CCX | Support, Patient Position |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
[00810045921051]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-31 |
Device Publish Date | 2020-07-23 |
00810045921082 | DuraHand, Extra Large - Surgical Advantage |
00810045921075 | DuraHand, Extra Large - Medical Products Resource |
00810045921068 | DuraHand, Extra Large - Integra Life Sciences |
00810045921051 | DuraHand, Extra Large |
00810045921044 | DuraHand, Large - Surgical Advantage |
00810045921037 | DuraHand, Large - Medical Products Resource |
00810045921020 | DuraHand, Large - Integra Life Sciences |
00810045921013 | DuraHand, Large |
00810045921006 | DuraHand, Pedi - Medical Products Resource |
00810045920993 | DuraHand, Pedi |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DURAHAND 76586183 3189741 Live/Registered |
Instrument Specialists, Inc. 2004-04-12 |