bd.comARISTA - Arista AH Absorbable Hemostatic Particles, 3g bellows container
2014-09-12
DAVOL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1223089 | 1000120505 | DAVOL INC. | 1 | N | 2026-01-01 | 160 New Boston St WOBURN MA US 01801 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00801741010125 | SIMPULSE - The Simpulse SOLO Suction/Irrigator | +1(800)562-0027 | medical.services@bd.com |
| 00801741010149 | SIMPULSE - The Simpulse SOLO System with Showerhead Tip | +1(800)562-0027 | medical.services@bd.com |
| 00801741010156 | SIMPULSE - The Simpulse SOLO System with Ultrex Retractable 1-1/4" Splash Shield Tip | +1(800)562-0027 | medical.services@bd.com |
| 00801741010309 | ULTREX - ULTREX Retractable Small Splash Shield Tip | +1(800)562-0027 | medical.services@bd.com |
| 00801741044106 | ARISTA - Arista AH Absorbable Hemostatic Particles, 3g bellows container | +1(800)562-0027 | medical.services@bd.com |
| 00801741044120 | ARISTA - Arista AH Absorbable Hemostatic Particles, 1g bellows container | +1(800)562-0027 | medical.services@bd.com |
| 00801741044144 | ARISTA - Arista AH Absorbable Hemostatic Particles, 5g bellows container | +1(800)562-0027 | medical.services@bd.com |
| 10801741233279 | GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Oval | +1(800)562-0027 | medical.services@bd.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36093 | 1751874277 | P800002 | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB | LMF | 1980-10-24 |
| 36093 | 1406439525 | P050038 | ARISTA AH ABSORBABLE HEMOSTAT | LMG | 2006-09-26 |
| 36093 | 1122010881 | N17600 | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) | LMF | 1976-08-26 |
| 36093 | 1562878235 | K161424 | Phasix Mesh | OOD | 2016-09-29 |
| 36093 | 1451532857 | K143380 | Phasix ST Mesh | OWT | 2015-06-05 |
| 36093 | 1870097065 | K142818 | Phasix Mesh | OOD | 2015-03-31 |
| 36093 | 1212652964 | K120728 | PHASIX PLUG AND PATCH | OWT | 2012-10-22 |
| 36093 | 1310693339 | K082687 | COLLAMEND FM IMPLANT | FTM | 2008-10-17 |
| 36093 | 1599984093 | K033666 | HEMADERM | QSY | 2003-12-17 |
| 36093 | 1430464710 |
Product Codes Associated With Registrations#
GUDID#
ARISTA - Arista AH Absorbable Hemostatic Particles, 1g bellows container
2014-09-11
ARISTA - Arista AH Absorbable Hemostatic Particles, 5g bellows container
2014-09-12
SIMPULSE - The Simpulse SOLO Suction/Irrigator
2015-12-23
SIMPULSE - The Simpulse SOLO System with Ultrex Retractable 1-1/4" Splash Shield Tip
2015-12-23
SIMPULSE - The Simpulse SOLO System with Showerhead Tip
2015-12-23
ULTREX - ULTREX Retractable Small Splash Shield Tip
2015-12-22
GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 6.4 cm x 18.5 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Oval
2026-04-30
GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Oval
2026-04-30
GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Oval
2026-04-30
OPTIFIX - OptiFix Absorbable Fixation System, 39 cm length, 5 mm diameter, 30 Fasteners
2015-04-16
OPTIFIX - OptiFix Absorbable Fixation System, 39 cm length, 5 mm diameter, 15 Fasteners
2015-04-16
GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 6.4 cm x 18.5 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Oval
2026-04-30
GalaFLEX 3D - GalaFLEX 3D Scaffold, 7.6 cm x 20.3 cm, Rectangle
2026-04-30
GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Oval
2026-04-30
GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Oval
2026-04-30
ONFLEX - "OnFlex Mesh, 4.0"" x 6.2"" (10.2 cm x 15.7 cm), Large"
2015-07-17
ONFLEX - "OnFlex Mesh, 3.4"" x 5.6"" (8.6 cm x 14.2 cm), Medium"
2015-07-17
Avitene - Syringe Avitene Microfibrillar Collagen Hemostat
2014-09-12
SIMPULSE - VariCare Retractable Small Splash Shield Wound Tip
2015-12-23
SURETRANS - SureTrans Autotransfusion System for Orthopaedics Drain Not Included
2015-06-17
Avitene - Avitene Flour, 1.0 gram
2014-09-12
Avitene - Avitene Flour, 0.5 gram
2014-09-12
Avitene - Avitene Non-Woven Web, 35 mm x 35 mm x 1 mm
2014-09-12
Avitene - Avitene Non-Woven Web, 70 mm x 35 mm x 1 mm
2014-09-10
Avitene - Avitene Non-Woven Web, 70 mm x 70 mm x 1 mm
2014-09-12
Avitene - Avitene Flour, 5.0 grams
2014-09-09
Avitene - "Avitene Ultrafoam, 2 cm x 6.25 cm x 7 mm (3/4"" x 2.5"" x 1/4""), 12.5 sq cm, 7mm"
2014-09-12
Avitene - "Avitene Ultrafoam, 8 cm x 6.25 cm (3-1/8"" x 2.5""), 50 sq cm"
2014-09-12
Avitene - "Avitene Ultrafoam, 8 cm x 12.5 cm (3-1/8"" x 5""), 100 sq cm"
2014-09-12
Avitene - "Avitene Ultrafoam, 8 cm x 12.5 cm (3-1/8"" x 5""), 100 sq cm, Thin"
2014-09-12
BARD - "Bard Mesh, 1"" x 4"" (2.5 cm x 10 cm)"
2015-04-15
BARD - "Bard Mesh, 2"" x 4"" (5 cm x 10 cm)"
2015-04-15
BARD - "Bard Mesh, 2"" x 12"" (5 cm x 31 cm)"
2015-04-15