FDA.reportPublic FDA data

ARROW

Primary DI
00801902048523
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN032667
Catalog number
ASK-00001-1A
Device description
Maximal Barrier Drape
Published
2016-09-16
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
KXXADHESIVE, DENTURE, KARAYA AND ETHYLENE-OXIDE HOMOPOLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXXAdhesive, Denture, Karaya And Ethylene-Oxide HomopolymerDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964142000MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSMedline Industries, Inc.1997-02-25KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902048524PackageGS120Not in Commercial Distribution
00801902048523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190204852430801902048524
00801902048523008019020485238019020485230801902048523

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50885380151499CONVERTORSCardinal Health 200, LLCKXX2017-06-12
D6620708881152PATTERSONPATTERSON DENTAL SUPPLY, INC.KXX2016-09-23
D6620708881156PATTERSONPATTERSON DENTAL SUPPLY, INC.KXX2016-09-23
30801902048524ARROWTELEFLEX INCORPORATEDKXX2016-09-16