Outake®

Primary DI
10884450045494
Brand
Outake®
Company
Merit Medical Systems, Inc.
Model
00884450045497
Catalog number
CET300
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063048000TRANS-CATHETER EXTRACTORTran Pa-C, Inc.2007-09-14ODY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450045494PackageGS18In Commercial Distribution
00884450045497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445004549410884450045494
00884450045497008844500454978844500454970884450045497

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603160040
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

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
00884450052587Outake®Merit Medical Systems, Inc.ODY2017-02-09
10884450052584Outake®Merit Medical Systems, Inc.ODY2017-02-09
00884450045497Outake®Merit Medical Systems, Inc.ODY2017-02-08