FDA.reportPublic FDA data

Getinge Pack Tyvek Roll

Primary DI
00850144008116
Brand
Getinge Pack Tyvek Roll
Company
PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
Model
GUTY2030
Catalog number
61301606735
Device description
Tyvek Roll 20cm x 30m
Published
2017-09-25
Public version status
Update
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
10850144008113PackageGS14In Commercial Distribution
00850144008116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085014400811310850144008113
00850144008116008501440081168501440081160850144008116

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4196935300rdean@lexamed.net

Regulatory Flags#

DUNS number
565751992
Device count
1
Lot or batch
true
Manufacturing date on label
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
10810105212102NEUSTERTP 1555082023-01-27
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

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Primary DI, Brand, Company table
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00840456201862JMUJMU DENTAL, INCFRG2026-06-05
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00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05