FDA.reportPublic FDA data

Purstring

Primary DI
10884521051478
Brand
Purstring
Company
Covidien LP
Model
020730
Device description
Purse String Device
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
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901107000MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATICUnited States Surgical, A Division of Tyco Healthc1990-04-09GDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521051475PackageGS13In Commercial Distribution
10884521051478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105147520884521051475
1088452105147810884521051478

GMDN Terms#

Term, Definition table
TermDefinition
Suture retention deviceA device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter

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
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
10884521840249TrexonGY323P2026-10-10
10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
10884521840379TrexonGY122P2026-10-10
10884521840409TrexonGY322P2026-10-10
10884521840430TrexonSY5628P2026-10-10
10884521840447TrexonSY5638P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434861MillenniumAvalign Technologies, Inc.GDJ2026-10-13
00190776433017MillenniumAvalign Technologies, Inc.GDJ2026-10-01
00190776433109MillenniumAvalign Technologies, Inc.GDJ2026-10-01
00190776432584MillenniumAvalign Technologies, Inc.GDJ2026-09-28
00190776430993MillenniumAvalign Technologies, Inc.GDJ2026-09-18
00190776426705MillenniumAvalign Technologies, Inc.GDJ2026-08-19
00850088713459PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713466PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713527PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00190776424497MillenniumAvalign Technologies, Inc.GDJ2026-08-07
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
00859261006265VBAS Extension ArmVYCOR MEDICAL, INC.GDJ2026-07-27
04059453072832Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2026-07-13
00850083275150Intrace USAPILOTIS TECH LLCGDJ2026-07-03
B8034906020ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906040ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906060ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906080ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906100ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906180ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906200ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906220ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906240ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906260ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
04052536085651neon3Ulrich GmbH & Co. KGGDJ2026-06-08
B7685610100Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-03-27
B7685610460Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10