FDA.reportPublic FDA data

Outake®

Primary DI
00884450052587
Brand
Outake®
Company
Merit Medical Systems, Inc.
Model
00884450052587
Published
2017-02-09
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

Product Codes#

Code, Name table
CodeName
ODYTunneled catheter remover

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODYTunneled Catheter RemoverGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450052584PackageGS18In Commercial Distribution
00884450052587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445005258410884450052584
00884450052587008844500525878844500525870884450052587

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Regulatory Flags#

DUNS number
603160040
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450110164Merit Disposal Depot™Initial ReleaseK10-00230D2026-08-07
00884450487402Merit Medical®Initial ReleaseK01-083682026-08-07
00884450500859Merit Medical®Initial ReleaseK09-10938D2026-08-08
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31
00884450500927Merit Medical®Initial ReleaseK12T-02563D2026-08-01
00884450838136Prelude Roadster™APG6F45R2026-07-31
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450486207Merit Medical®Initial ReleaseK12T-12645C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450051337Outake®Merit Medical Systems, Inc.ODY2017-02-15
10884450051334Outake®Merit Medical Systems, Inc.ODY2017-02-15
10884450052584Outake®Merit Medical Systems, Inc.ODY2017-02-09
00884450045497Outake®Merit Medical Systems, Inc.ODY2017-02-08
10884450045494Outake®Merit Medical Systems, Inc.ODY2017-02-08