FDA.reportPublic FDA data

Embosafe

Primary DI
H787065076020
Brand
Embosafe
Company
ANGIODYNAMICS, INC.
Model
06507602
Device description
Valved Peelable Introducer Sheath
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQRCANNULA, CATHETER
DQXWIRE, GUIDE, CATHETER
DRCTrocar
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQRCannula, CatheterCardiovascular2
DQXWire, Guide, CatheterCardiovascular2
DRCTrocarCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051655000ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.2005-09-12DQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787065076025PackageHIBCC5In Commercial Distribution
H787065076020PrimaryHIBCC0
15051684012119SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401211915051684012119

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787140650Syntrax Support Catheter14-0652021-11-02
H787140900Syntrax Support Catheter14-0902021-11-02
H787141350Syntrax Support Catheter14-1352021-11-02
H787141500Syntrax Support Catheter14-1502021-11-02
H787141800Syntrax Support Catheter14-1802021-11-02
H787180650Syntrax Support Catheter18-0652021-11-02
H787180900Syntrax Support Catheter18-0902021-11-02
H787181350Syntrax Support Catheter18-1352021-11-02
H787181500Syntrax Support Catheter18-1502021-11-02
H787181800Syntrax Support Catheter18-1802021-12-16
H787350650Syntrax Support Catheter35-0652021-11-02
H787350900Syntrax Support Catheter35-0902021-11-02
H787351350Syntrax Support Catheter35-1352021-11-02
H787351500Syntrax Support Catheter35-1502021-11-02
H787351801Syntrax Support Catheter35-1802021-11-02
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00884450735916Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735906Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735920Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735944Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735968Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735975Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735999Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736033Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736057Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736071Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736118Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736132Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736149Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736187Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736224Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736262Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736309Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736361Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736385Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736439Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736446Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736491Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736507Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736552Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739317Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739348Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739379Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14