FDA.reportPublic FDA data

Powered Multifire Endo GIA

Primary DI
10884523003802
Brand
Powered Multifire Endo GIA
Company
Covidien LP
Model
030302
Catalog number
030302
Device description
Powered Stapler
Published
2015-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDWSTAPLE, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913802000AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLERUnited States Surgical, A Division of Tyco Healthc1991-10-17GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884523003809PackageGS13In Commercial Distribution
10884523003802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300380920884523003809
1088452300380210884523003802

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
Height3.5Millimeter
Length60Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
66925776119311easyLCTM Linear Cutter Staplers and Loading Units for Single UseEzisurg Medical Co., Ltd.GDW2026-02-04
06946480501276Disposable Circular StaplersSinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480503638Disposable Linear Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480510537Disposable Curved Cutter Staplers Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480563632Disposable Linear Staplers and ReloadsSinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480576052Disposable Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480576151Disposable Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589311Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589366Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589373Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
30705036040792ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
20705036040818ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
30705036040822ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
20705036040856ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10886874123642SureFormINTUITIVE SURGICAL, INC.GDW2025-06-20
24026704921724TELEFLEXTELEFLEX INCORPORATEDGDW2025-05-13
14026704921772TELEFLEXTELEFLEX INCORPORATEDGDW2025-05-13
34026704921783TELEFLEXTELEFLEX INCORPORATEDGDW2025-05-13
00850060791154AEONLEXINGTON MEDICAL, INC.GDW2025-05-01
00850060791130AEONLEXINGTON MEDICAL, INC.GDW2025-02-18
20884521827643EEACovidien LPGDW2025-02-07
20884521827650EEACovidien LPGDW2025-02-07
20884521827667EEACovidien LPGDW2025-02-07
00850060791109AEONLEXINGTON MEDICAL, INC.GDW2025-01-09
16925776112577easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112584easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112591easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112607easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112614easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112621easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07