FDA.reportPublic FDA data

Saffron

Primary DI
05708932757690
Brand
Saffron
Company
Coloplast A/S
Model
520350
Catalog number
520350
Device description
Anchor
Published
2022-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBQFixation, non-absorbable or absorbable, for pelvic use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBQFixation, Non-Absorbable Or Absorbable, For Pelvic UseObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220420000Saffron Fixation SystemColoplast A/S2022-06-10PBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932757430PackageGS112In Commercial Distribution
05708932757690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932757430057089327574305708932757430
05708932757690057089327576905708932757690

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

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
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
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019174219Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174226Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174233Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174240Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174257Mendit Retriver Universal SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174431Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174448Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174455Mendit securement element setESCALA MEDICAL LTDPBQ2026-03-10
17290017082056EnPlace Refill KitFEMSELECT LTDPBQ2026-01-08
07290019174097Mendit applicator set ESCALA MEDICAL LTDPBQ2024-06-05
07290019174103Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174110Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174127Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174134Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174141Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174158Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174165Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174172Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174189Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174196Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174202Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174035Mendit Applicator SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174042Mendit Retriever SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174059Mendit Reload SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174400Mendit Applicator SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174417Mendit Retriever SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174424Mendit Reload SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174004APYX Applicator SetESCALA MEDICAL LTDPBQ2023-08-06
07290019174028Mendit Reload SetESCALA MEDICAL LTDPBQ2023-06-25
07290019174011APYX Retriever SetESCALA MEDICAL LTDPBQ2022-11-06