StatSeal® DE021
GUDID 00834061000217
StatSeal® Disc X-treme
BIOLIFE, L.L.C.
Non-organic haemostatic agent| Primary Device ID | 00834061000217 |
| NIH Device Record Key | a67b295b-16a6-493b-bcdb-1f5797eb4391 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StatSeal® |
| Version Model Number | DE021 |
| Catalog Number | DE021 |
| Company DUNS | 135872476 |
| Company Name | BIOLIFE, L.L.C. |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com |
Device Dimensions
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
| Outer Diameter | 5.04 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00834061000217 [Primary] |
| GS1 | 00834061006219 [Package] Package: Case [10 Units] In Commercial Distribution |
| GS1 | 00834061006417 [Package] Package: Case [40 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130324
FDA Product Code
| FRO | Dressing, Wound, Drug |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
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 | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
On-Brand Devices [StatSeal® ]
| 00834061000200 | StatSeal® Disc - Advanced RAD - 1 Application |
| 00834061000194 | StatSeal® Disc - Advanced Plus - 1 Application |
| 00834061000187 | StatSeal® Disc - Advanced - 1 Application |
| 00834061000170 | StatSeal® Disc - Extra Large - 1 Application |
| 00834061000163 | StatSeal® Disc - Large - 1 Application |
| 00834061000156 | StatSeal® Disc - Medium - 1 Application |
| 00834061000149 | StatSeal® Disc - Small - 1 Application |
| 00834061000132 | StatSeal® Disc - Extra Small - 1 Application |
| 00834061000071 | StatSeal® Advanced Powder - 1 Application |
| 00834061000064 | StatSeal® Powder - 1 Application |
| 00834061000217 | StatSeal® Disc X-treme |
Trademark Results [StatSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STATSEAL 87650094 5475113 Live/Registered |
Biolife, L.L.C. 2017-10-18 |
 STATSEAL 85449674 4211526 Live/Registered |
Biolife, LLC 2011-10-18 |
 STATSEAL 78232885 not registered Dead/Abandoned |
EH Ventures, LLC 2003-04-02 |
 STATSEAL 75246378 not registered Dead/Abandoned |
Vascular Solutions, Inc. 1997-02-24 |
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