FDA.reportPublic FDA data

NA

Primary DI
10888551007931
Brand
NA
Company
STERILMED, INC.
Model
COOCTI-512N
Catalog number
COOCTI-512N, COOCTI-512N-5
Device description
Carter-Thomason CloseSure System
Published
2016-09-22
Public version status
Update
Distribution status
Not 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
K133414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133414000REPROCESSED CLOSURE SYSTEMSterilmed, Inc.2014-01-22NLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888551007945PackageGS15Not in Commercial Distribution
10888551007931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088855100794520888551007945
1088855100793110888551007931

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15
10888551045445NASYN03.312.410SYN03.312.4102019-11-15

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