FDA.reportPublic FDA data

NEUSTER

Primary DI
10810105212102
Brand
NEUSTER
Company
PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
Model
TP 155508
Device description
Sterilization Pouch made of DuPont™ Tyvek® 15,5 cm x 50,8 cm
Published
2023-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160595000PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti2016-11-18FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810105212112PackageGS14In Commercial Distribution
10810105212102PrimaryGS10
00810105212105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810105212112008101052121128101052121120810105212112
1081010521210210810105212102
00810105212105008101052121058101052121050810105212105

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+903242387042derya.dikici@pmsmedikal.com

Regulatory Flags#

DUNS number
565751992
Device count
250
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810105212065NEUSTERTP 1526582023-01-27
10810105212089NEUSTERTP 1527852023-01-27
10810105211921NEUSTERTP 631152023-01-26
10810105211945NEUSTERTP 83302023-01-26
10810105211969NEUSTERTP 891652023-01-26
10810105211983NEUSTERTP 114182023-01-26
10810105212003NEUSTERTP 12602023-01-26
10810105212027NEUSTERTP 127252023-01-26
10810105212041NEUSTERTP 124552023-01-26
10810105211884NEUSTERTP 05092023-01-24
10810105211907NEUSTERTP 57252023-01-24
00810105211863NEUSTERTY 2032252023-01-24
00850144008932BENCO DENTALFL 75305952-4272022-02-09
00850144008949BENCO DENTALFL 10305952-4542022-02-09
00850144008956BENCO DENTALFL 15305952-4632022-02-09
00850144008857BENCO DENTALFL 75305952-4272022-02-09
00850144008864BENCO DENTALFL 10305952-4542022-02-09
00850144008871BENCO DENTALFL 15305952-4632022-02-09
00850144008925BENCO DENTALFL 05305952-4452022-02-07
00850144008840BENCO DENTALFL 05305952-4452022-02-07

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Primary DI, Brand, Company table
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00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
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00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
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00840456201930JMUJMU DENTAL, INCFRG2026-06-05
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00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
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00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05