FDA.reportPublic FDA data

GIA Premium

Primary DI
10884521031630
Brand
GIA Premium
Company
Covidien LP
Model
030735L
Device description
Loading Unit
Published
2018-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
K801590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801590000AUTO SUTURE DISPOSABLE GIA SURG. STAPLERUnited States Surgical, A Division of Tyco Healthc1980-08-04FHM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521031637PackageGS16Not in Commercial Distribution
10884521031630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452103163720884521031637
1088452103163010884521031630

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3.8Millimeter
Length90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521824355McGRATHX3-003-0002021-09-01
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10884521049024TA 90 BNCovidien 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