FDA.reportPublic FDA data

Endo Catch II

Primary DI
10884523000948
Brand
Endo Catch II
Company
Covidien LP
Model
173049
Device description
Specimen Retrieval Pouch
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCILARYNGOSCOPE, ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCILaryngoscope, EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922123000AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHUnited States Surgical, A Division of Tyco Healthc1993-02-01GCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884523000945PackageGS13In Commercial Distribution
10884523000948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300094520884523000945
1088452300094810884523000948

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter15Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776419691MillenniumAvalign Technologies, Inc.GCI2026-08-25
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.GCI2026-04-30
G4533352505380PEAK MEDICALPeak Medical Distribution Inc.GCI2024-10-09
10850048763194Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763200Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763217Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763224Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763231Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763248Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763255Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763262Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763279Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763286Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763309Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763354Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763613Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763620Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763637Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763651Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10884523000955Endo Catch GoldCovidien LPGCI2016-09-24
20884523000945Endo Catch IICovidien LPGCI2016-09-24
20884523000952Endo Catch GoldCovidien LPGCI2016-09-24
30884521164820SurgiSleeveCovidien LPGCI2016-09-24
30884521164837SurgiSleeveCovidien LPGCI2016-09-24
20884521164816SurgiSleeveCovidien LPGCI2016-09-24