FDA.reportPublic FDA data

Novapass

Primary DI
00827002351196
Brand
Novapass
Company
COOK INCORPORATED
Model
G35119
Catalog number
C-PAS-180-16.0
Device description
Novapass Straight Suture Passer
Published
2020-10-02
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
GEJCARRIER, LIGATURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEJCarrier, LigatureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002351193PackageGS13In Commercial Distribution
00827002351196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700235119310827002351193
00827002351196008270023511968270023511960827002351196

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397173MillenniumAvalign Technologies, Inc.GEJ2026-07-16
16975808861300MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861317MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861324MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861331MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861348MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861355MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861362MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861379MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861386MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861303MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861310MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861327MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861334MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861341MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861358MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861365MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861372MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861389MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
10840113298782CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
10840113299765CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
20840113299076CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00814707024043CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00194613014438MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2025-08-01
00194613063443MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091439MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091484MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00887482041444Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482041451Symmetry DeschASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482054918Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15