HemaDerm ENT0001-2
GUDID 10801741044080
ENT Kit with HemaDerm Topical Hemostat
Davol Inc.
Plant polysaccharide haemostatic agent, bioabsorbable| Primary Device ID | 10801741044080 |
| NIH Device Record Key | a3d80ec3-90cb-4da2-ad1f-d4d7fda20223 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemaDerm |
| Version Model Number | ENT0001-2 |
| Catalog Number | ENT0001-2 |
| Company DUNS | 001191048 |
| Company Name | Davol Inc. |
| 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 | 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)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com | |
| Phone | +1(800)556-6275 |
| medical.services@bd.com |
Device Dimensions
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 60 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741044083 [Primary] |
| GS1 | 10801741044080 [Package] Contains: 00801741044083 Package: CA [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033666
FDA Product Code
| NHB | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
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 | 2023-10-17 |
| Device Publish Date | 2023-10-09 |
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 [HemaDerm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMADERM 78167906 2803752 Live/Registered |
Medafor Inc 2002-09-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.