FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489000597
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CTI1015NR
Catalog number
CTI1015NR
Device description
CTI-1015N CARTER THOMASON SUTURE PA
Published
2025-01-29
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
20193489000594PackageGS15In Commercial Distribution
10193489000597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348900059420193489000594
1019348900059710193489000597

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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

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
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
10888277379060MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29