FDA.reportPublic FDA data

TA 90 BN

Primary DI
10884521049024
Brand
TA 90 BN
Company
Covidien LP
Model
010885
Catalog number
010885
Device description
Reusable Notched Bariatric Stapler
Published
2018-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHMAPPARATUS, SUTURING, STOMACH AND INTESTINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHMApparatus, Suturing, Stomach And IntestinalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K801589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801589000AUTO SUTURE DISP. 30, ETC. & SURG. STAPUnited States Surgical, A Division of Tyco Healthc1980-08-04FHM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521049024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452104902410884521049024

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery manual linear stapler, reusableA hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length90Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733103322Para-Pak CLEANMERIDIAN BIOSCIENCE, INC.FHM2021-06-18
10884521048980TA PremiumCovidien LPFHM2018-08-19
10884521031630GIA PremiumCovidien LPFHM2018-08-10
10884521045965Premium Multifire TACovidien LPFHM2018-08-10
10884523007091GIA PremiumCovidien LPFHM2018-08-10
20884521045962Premium Multifire TACovidien LPFHM2018-08-10
20884523007098GIA PremiumCovidien LPFHM2018-08-10
10884521063402GIA PremiumCovidien LPFHM2018-08-10
10884521048997TA PremiumCovidien LPFHM2018-08-10
10884521049000TA PremiumCovidien LPFHM2018-08-10
20884521031637GIA PremiumCovidien LPFHM2018-08-10
00815277020633CuraplexBOUND TREE MEDICAL, LLCFHM2016-12-14
00815277027779CuraplexBOUND TREE MEDICAL, LLCFHM2016-12-14
00815277027786CuraplexBOUND TREE MEDICAL, LLCFHM2016-12-14
00613994941770Pro-Flo™MEDTRONIC, INC.FHM2016-06-13
20613994941774Pro-Flo™MEDTRONIC, INC.FHM2016-06-13