WoundSeal® DWS001
GUDID 00834061000255
WoundSeal® Disc - Advanced
BIOLIFE, L.L.C.
Non-organic haemostatic agent| Primary Device ID | 00834061000255 |
| NIH Device Record Key | 6c16b115-5b78-4e5b-a12f-27b818366dd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WoundSeal® |
| Version Model Number | DWS001 |
| Catalog Number | DWS001 |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
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 | 00834061000255 [Primary] |
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 [WoundSeal®]
| 00834061003201 | WoundSeal® Rapid Response - 1 Application |
| 00834061003195 | WoundSeal® Rapid Response - 1 Application |
| 00834061003102 | WoundSeal® Powder - 2 Applications |
| 00834061000491 | WoundSeal® Powder - 2 Applications |
| 00834061000477 | WoundSeal® Powder - 2 Applications |
| 00834061000453 | WoundSeal® Powder - 2 Applications |
| 00834061000446 | WoundSeal® + Applicator - 2 Applications |
| 00834061000392 | WoundSeal® + Applicator - 2 Applications |
| 00834061000378 | WoundSeal® + Applicator - 1 Application |
| 00834061000101 | WoundSeal® + Applicator - 2 Applications |
| 00834061000057 | WoundSeal® MD + Applicator - 1 Application |
| 00834061000040 | WoundSeal® Powder - 4 Applications |
| 00834061000026 | WoundSeal® + Applicator - 1 Application |
| 00834061006318 | WoundSeal® Rapid Response - 1 Application |
| 00834061002358 | WoundSeal® Powder |
| 00834061000255 | WoundSeal® Disc - Advanced |
Trademark Results [WoundSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WOUNDSEAL 86373258 4715748 Live/Registered |
Biolife, L.L.C. 2014-08-21 |
 WOUNDSEAL 78480855 not registered Dead/Abandoned |
KCI Licensing, Inc. 2004-09-09 |
 WOUNDSEAL 77707312 3750868 Live/Registered |
Biolife LLC 2009-04-06 |
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