FDA.reportPublic FDA data

Medline

Primary DI
10193489000634
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
CTI512NR
Catalog number
CTI512NR
Device description
CTI-512N CT CLOSESURE SYSTEM WHITE
Published
2023-10-09
Public version status
New
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
NLMLaparoscope, general & plastic surgery, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLMLaparoscope, General & Plastic Surgery, ReprocessedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182828000Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserSurgical Instrument Service and Savings, Inc.2019-04-15NLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489000631PackageGS15In Commercial Distribution
10193489000634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348900063120193489000631
1019348900063410193489000634

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reprocessedA 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 previously used single-use device that has been processed for an additional single-use patient application.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277385511MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-07-18
10888277386167MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-04-17
20888277386164MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-04-17
10888277386761MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-03-01
20888277386768MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-03-01
10888277372450MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-02-14
10888277384484MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-02-14
20888277372457MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-02-14
20888277384481MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-02-14
10888277372597MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-31
20888277372594MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-31
10080196374649MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10193489000597MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277372443MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277372474MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277373976MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277373990MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374027MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374577MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374584MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374591MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374607MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374614MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376632MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376649MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376656MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376663MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376670MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277377776MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277378742MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29