Exair

Primary DI
05708932459433
Brand
Exair
Company
Coloplast A/S
Model
50150
Catalog number
50150
Device description
Prolapse Repair System - Posterior
Published
2015-10-22
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
OTPMesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedObstetrics/Gynecology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932459433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932459433057089324594335708932459433

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 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; it may in addition knot and/or cut the sutures as they are placed. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
05708932588942Freedom Clear5057415057412022-12-06
05708932957847Freedom Clear5057315057312022-12-06
05708932125338SpeediCath Flex Coude Pro20012200122019-07-12
05708932125369SpeediCath Flex Coude Pro20014200142019-07-12
05701780348317Luja Soft20171201712026-10-01
05701780348348Luja Soft20172201722026-10-01
05701780348379Luja Soft20174201742026-10-01
05701780348409Luja Soft20176201762026-10-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814723020050ElevateENDO PHARMACEUTICALS INC.OTP2015-10-24
00814723020067ElevateENDO PHARMACEUTICALS INC.OTP2015-10-24
05708932459457ExairColoplast A/SOTP2015-10-22
08714729839200Uphold™ LITEBOSTON SCIENTIFIC CORPORATIONOTP2015-09-24