HOLTER® 82-1695
GUDID 00381780515534
Type B Fixation and Joining Connector Straight
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector Cerebrospinal fluid shunt connector| Primary Device ID | 00381780515534 |
| NIH Device Record Key | f6d2ccdc-6a73-4e19-bedd-664aeaa61d5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HOLTER® |
| Version Model Number | 821695 |
| Catalog Number | 82-1695 |
| 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 | |
| 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 |
| 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 | 00381780515534 [Unit of Use] |
| GS1 | 10381780515531 [Primary] |
| GS1 | 10886704040743 [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 |
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
Moist Heat or Steam Sterilization
[00381780515534]
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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