FDA.reportPublic FDA data

Signia

Primary DI
10884521703704
Brand
Signia
Company
Covidien LP
Model
SIGCIRTP
Catalog number
SIGCIRTP
Device description
Circular Adapter Reusable Trocar Tip Protector
Published
2019-06-28
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
GDWStaple, implantable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182475000Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)Covidien2019-03-14GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521703704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452170370410884521703704

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit105 Degrees Fahrenheit
Special Storage Condition, Specify00No;
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255200005MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200012MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200029MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909590MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909606MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909613MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909620MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909637MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909644MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909941MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909958MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909965MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909972MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909989MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
10705036040798ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040811ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040828ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040859ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027904Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
M06760001020Integrity Implant Fixation KitAnika Therapeutics, Inc.GDW2023-11-14
10705036022916N/AETHICON ENDO-SURGERY, LLCGDW2022-01-20
10705036022923N/AETHICON ENDO-SURGERY, LLCGDW2022-01-20