FDA.reportPublic FDA data

Avitene Non-Woven Web

Primary DI
10801741010467
Brand
Avitene Non-Woven Web
Company
Davol Inc.
Model
1010090
Catalog number
1010090
Device description
Avitene Microfibrillar Collagen Hemostat Non-Woven Web
Published
2014-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMFAgent, absorbable hemostatic, collagen based

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMFAgent, Absorbable Hemostatic, Collagen BasedGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P800002000
P800002001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P800002000AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEBC.R. Bard, Inc.1980-10-24LMF
P800002001AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEBC.R. Bard, Inc.1980-10-24LMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741010467PackageGS16In Commercial Distribution
00801741010460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101046710801741010467
00801741010460008017410104608017410104600801741010460

GMDN Terms#

Term, Definition table
TermDefinition
Collagen haemostatic agentA sterile, bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1Millimeter
Length70Millimeter
Width35Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags#

DUNS number
001191048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741233279GalaFLEX 3DRFR3D02BDFR3D02BD2026-04-30
10801741233521GalaFLEX 3DSH3D02BDSH3D02BD2026-04-30
10801741234368GalaFLEX 3DSH3D04BDSH3D04BD2026-04-30
10801741234382GalaFLEX 3DSH3D06BDSH3D06BD2026-04-30
10801741234412GalaFLEX 3DRFR3D04BDFR3D04BD2026-04-30
10801741234436GalaFLEX 3DRFR3D06BDFR3D06BD2026-04-30
00801741074318OPTIFIX011312601131262015-04-16
00801741074325OPTIFIX011312701131272015-04-16
00801741233265GalaFLEX 3DRFR3D01BDFR3D01BD2026-04-30
00801741233494GalaFLEX 3DSH3D01BDSH3D01BD2026-04-30
00801741234354GalaFLEX 3DSH3D03BDSH3D03BD2026-04-30
00801741234378GalaFLEX 3DSH3D05BDSH3D05BD2026-04-30
00801741234392GalaFLEX 3DSH3D07BDSH3D07BD2026-04-30
00801741234408GalaFLEX 3DRFR3D03BDFR3D03BD2026-04-30
00801741234422GalaFLEX 3DRFR3D05BDFR3D05BD2026-04-30
00801741074431ONFLEX011541101154112015-07-17
00801741074424ONFLEX011541001154102015-07-17
00801741010507Avitene101034010103402014-09-12
00801741065323SIMPULSE006731000673102015-12-23
00801741065439SURETRANS859500085950002015-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15712123000646SURGIFLO™ Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2026-01-05
25712123000643SURGIFLO™ Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2026-01-05
00801741223105AviteneDavol Inc.LMF2023-06-27
10801741223102AviteneDavol Inc.LMF2023-06-27
10381780508656OraFOAM™Integra Lifesciences CorporationLMF2019-02-04
00300092250018GEL-FLOW KITPHARMACIA & UPJOHN COMPANY LLCLMF2018-08-17
00300091040016GEL-FLOW™ NTPHARMACIA & UPJOHN COMPANY LLCLMF2018-04-17
00300091040061GEL-FLOW™ NTPFIZER INC.LMF2018-04-17
00085412086309Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2017-12-21
50085412086304Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2017-12-21
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
00085412096124Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
50085412096105Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
00360793310107GELFOAM-JMI™ Sponge KitPHARMACIA & UPJOHN COMPANY LLCLMF2017-06-05
00360793410104GELFOAM-JMI™ Powder KitPHARMACIA & UPJOHN COMPANY LLCLMF2017-06-05
00085412095158Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
00085412095165Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
50085412095153Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
50085412095160Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
15712123000288SURGIFLO® Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2016-05-10
00085412096094Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2015-05-22
00085412096117Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2015-05-22
00085412091006Floseal Special Applicator TipsBAXTER HEALTHCARE CORPORATIONLMF2015-05-14
50085412091001Floseal Special Applicator TipsBAXTER HEALTHCARE CORPORATIONLMF2015-05-14
00808232000801VitagelStryker OrthobiologicsLMF2014-09-24
00808232000818VitagelStryker OrthobiologicsLMF2014-09-24
00808232001242VitaPrepStryker CorporationLMF2014-09-24
00808232001389VitagelStryker CorporationLMF2014-09-24
00808232001396VitagelStryker CorporationLMF2014-09-24
15712123000264SURGIFOAM® Absorbable Gelatin Powder KitFerrosan Medical Devices A/SLMF2014-09-24