FDA.reportPublic FDA data

NA

Primary DI
20888551007945
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20888551007945PackageGS15In 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 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 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
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