FDA.reportPublic FDA data

Auto Suture

Primary DI
10884521184466
Brand
Auto Suture
Company
Covidien LP
Model
098002
Device description
CoPilot System
Published
2018-08-10
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
IZDProbe, uptake, nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961321000GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.1997-02-10IZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521184463PackageGS112In Commercial Distribution
10884521184466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452118446320884521184463
1088452118446610884521184466

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

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
10884521171534Nellcor10005941-SG2022-10-01
10884521163454Nellcor100059412016-09-24
10884521196728NellcorPM100N2016-09-24
10884521527607NellcorDLPM100N2017-08-03
10884521527591NellcorDSPM100N2017-05-29
40884522004061ShileyDDCP2015-09-01
10884521815353MicrostreamPMC40M-PH2023-06-12
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103615NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
00841911103622NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
B619K0018C01UP0GammaPro Straight Standard ProbeKubtecIZD2025-03-26
B619K0019C01UW0GammaPro High Sensitivity ProbeKubtecIZD2025-03-26
B619K0020C01TA0GammaPro Laparoscopic ProbeKubtecIZD2025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeKubtecIZD2025-03-26
00841911102526neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102533neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102540neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102557neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-07-31
04260152884415Navigator 3 Wired Probe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884422Navigator 3 Wired Probe Cablecrystal-photonics GmbHIZD2024-03-19
04260152884484Navigator 3 Wired Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884491Navigator 3 WirelessPprobe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884507Navigator 3 Wireless Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884514Navigator 3 Wireless Probe Battery Packcrystal-photonics GmbHIZD2024-03-19
04260152887102Navigator 3 Control Unitcrystal-photonics GmbHIZD2024-03-19
00860008268907Node Seeker 2000INTRA MEDICAL IMAGING LLCIZD2023-05-03
08437018413294GAMMAPROGENERAL EQUIPMENT FOR MEDICAL IMAGING SAIZD2023-01-18
B939CW5APO1050CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
B939CW5APO1060CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
00850014578008Lara ReaderLUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578015Lara Sensor, Type 1LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578022Lara Sensor, Type 2LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578039Lara Sensor, Type 3LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578046Lara Sensor, Type 4LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578053Lara Sensor, Type 5LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578060Lara Sensor, Type 6LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578077Lara Sensor, Type 7LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578084Lara Sensor, Type 8LUCERNO DYNAMICS, LLCIZD2023-01-01