HOLTER® 82-1694
GUDID 00381780515527
Type A Fixation and Joining Connector Straight
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Cerebrospinal fluid shunt connector| Primary Device ID | 00381780515527 |
| NIH Device Record Key | dcca0ab8-b803-402d-85c0-c3cca0493a05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HOLTER® |
| Version Model Number | 821694 |
| Catalog Number | 82-1694 |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | false |
| 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
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381780515527 [Unit of Use] |
| GS1 | 10381780515524 [Primary] |
| GS1 | 10886704040736 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102961
FDA Product Code
| JXG | Shunt, central nervous system and components |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
[00381780515527]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2020-06-02 |
On-Brand Devices [HOLTER®]
| 00381780515534 | Type B Fixation and Joining Connector Straight |
| 00381780515527 | Type A Fixation and Joining Connector Straight |
Trademark Results [HOLTER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HOLTER 72339166 0919345 Dead/Cancelled |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 1969-09-29 |
 HOLTER 72335218 0924766 Live/Registered |
EXTRACORPOREAL MEDICAL SPECIALTIES, INC. 1969-08-13 |
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