FDA.reportPublic FDA data

Digitex

Primary DI
05708932504041
Brand
Digitex
Company
Coloplast A/S
Model
52032
Catalog number
52032
Device description
Absorbable Suture Cartridge with Needle - Polyglycolic Acid Coated
Published
2015-10-28
Public version status
Update
Distribution status
Not 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
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120284000DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEXColoplast A/S2012-05-23NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932504058PackageGS112Not in Commercial Distribution
05708932504041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932504058057089325040585708932504058
05708932504041057089325040415708932504041

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14
05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14
00762123030196Conveen Security+21346213462022-03-11
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224453MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837224491MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337214MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031464278STRATAFIXETHICON, LLCGAM2023-03-24
10705031464285STRATAFIXETHICON, LLCGAM2023-03-24
10705031464292STRATAFIXETHICON, LLCGAM2023-03-24
10705031464308STRATAFIXETHICON, LLCGAM2023-03-24
10705031464315STRATAFIXETHICON, LLCGAM2023-03-24
10705031464322STRATAFIXETHICON, LLCGAM2023-03-24
10705031464339STRATAFIXETHICON, LLCGAM2023-03-24
10705031464346STRATAFIXETHICON, LLCGAM2023-03-24
10705031464353STRATAFIXETHICON, LLCGAM2023-03-24
10705031464360STRATAFIXETHICON, LLCGAM2023-03-24
10705031464377STRATAFIXETHICON, LLCGAM2023-03-24
10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
10705031464391STRATAFIXETHICON, LLCGAM2023-03-24
10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24