HaloShield C-SHIELD-1.0
GUDID 10827002462899
HaloShield Nipple Protector
COOK BIOTECH INCORPORATED
Wound shield| Primary Device ID | 10827002462899 |
| NIH Device Record Key | 373f8ad4-9fd2-4cf9-b9f7-93b5d11bd8e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HaloShield |
| Version Model Number | G46289 |
| Catalog Number | C-SHIELD-1.0 |
| Company DUNS | 945385862 |
| Company Name | COOK BIOTECH INCORPORATED |
| 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 | false |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002462892 [Primary] |
| GS1 | 10827002462899 [Package] Contains: 00827002462892 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K905766
FDA Product Code
| GBX | CATHETER, IRRIGATION |
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 | 2019-03-19 |
| Device Publish Date | 2019-03-11 |
On-Brand Devices [HaloShield]
| 10827002462905 | HaloShield Nipple Protector |
| 10827002462899 | HaloShield Nipple Protector |
Trademark Results [HaloShield]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HALOSHIELD 90681767 not registered Live/Pending |
Corrosion and Abrasion Solutions (USA) Ltd. 2021-04-29 |
 HALOSHIELD 86959098 5312386 Live/Registered |
Cook Medical Technologies LLC 2016-03-31 |
 HALOSHIELD 86053565 4693109 Live/Registered |
Sanosil International, LLC 2013-09-02 |
 HALOSHIELD 77212275 4324622 Live/Registered |
SALK, INC. 2007-06-21 |
 HALOSHIELD 76262800 2811150 Live/Registered |
SALK, INC. 2001-05-25 |
 HALOSHIELD 75299404 not registered Dead/Abandoned |
HALOSOURCE CORPORATION 1997-05-29 |
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