Avitene 1020010
GUDID 10801741223102
Avitene Flowable Collagen Hemostat
Davol Inc.
Collagen haemostatic agent, non-antimicrobial| Primary Device ID | 10801741223102 |
| NIH Device Record Key | d80936bb-01d7-4e5e-91f7-d257ab07c821 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avitene |
| Version Model Number | 1020010 |
| Catalog Number | 1020010 |
| Company DUNS | 001191048 |
| Company Name | Davol Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com |
Device Dimensions
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741223105 [Primary] |
| GS1 | 10801741223102 [Package] Contains: 00801741223105 Package: EA [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: N17600
FDA Product Code
| LMF | Agent, absorbable hemostatic, collagen based |
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 | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
Devices Manufactured by Davol Inc.
| 00801741233678 - GalaFLEX | 2025-10-03 GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle |
| 00801741233685 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 5.0 cm x 15.0 cm, Rectangle |
| 00801741233692 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 5.0 cm x 20.0 cm, Rectangle |
| 00801741233708 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 10.0 cm x 20.0 cm, Rectangle |
| 00801741233715 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 15.0 cm x 20.0 cm, Rectangle |
| 00801741233722 - GalaFLEX LITE | 2025-10-03 GalaFlex LITE Scaffold, 2.5 cm x 7.6 cm, Rectangle |
| 00801741233739 - GalaFLEX LITE | 2025-10-03 GalaFlex LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle |
| 00801741233746 - GalaFLEX LITE | 2025-10-03 GalaFlex LITE Scaffold, 5.0 cm x 20.0 cm, Rectangle |
Trademark Results [Avitene]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVITENE 73100994 1064805 Live/Registered |
AVICON, INC. 1976-09-24 |
 AVITENE 72247210 0823930 Dead/Expired |
FMC CORPORATION 1966-06-03 |
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