BioCol 8-050-001
GUDID 00745713086018
1 gram Collagen Powder
Southwest Technologies, Inc.
Collagen wound matrix dressing| Primary Device ID | 00745713086018 |
| NIH Device Record Key | 82f031fd-8942-40d0-89d4-ee25401d5f9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioCol |
| Version Model Number | AWC01 |
| Catalog Number | 8-050-001 |
| Company DUNS | 048078018 |
| Company Name | Southwest Technologies, Inc. |
| Device Count | 15 |
| 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
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00745713086018 [Unit of Use] |
| GS1 | 00745713186015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030774
FDA Product Code
| KGN | Wound dressing with animal-derived material(s) |
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 | 2023-03-01 |
| Device Publish Date | 2023-02-21 |
On-Brand Devices [BioCol]
| 00745713086025 | 5 gram Collagen Powder |
| 00745713086018 | 1 gram Collagen Powder |
Trademark Results [BioCol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOCOL 78938296 3501895 Dead/Cancelled |
Biocol-Laboratorios Farmaco e Cosmetico, Lda 2006-07-26 |
 BIOCOL 75859323 2590341 Dead/Cancelled |
SANTAMARIA ALCOCER, MARIA DOLORES 1999-11-29 |
 BIOCOL 75491881 not registered Dead/Abandoned |
TRACE SCIENTIFIC LTD 1998-05-28 |
 BIOCOL 75055131 not registered Dead/Abandoned |
Trace America, Inc. 1996-02-08 |
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