Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm 12741.13873

GUDID 04260462742184

Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm

Pemax Kunststoff GmbH

Medical equipment drape, single-use
Primary Device ID04260462742184
NIH Device Record Key8a7bfec7-5304-43a1-8116-332716a90dc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm
Version Model Number12741.13873
Catalog Number12741.13873
Company DUNS341672714
Company NamePemax Kunststoff GmbH
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de
Phone+4974415204900
Emailinfo@pemax.de

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260462742160 [Primary]
GS104260462742177 [Unit of Use]
GS104260462742184 [Package]
Contains: 04260462742160
Package: Box [4 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-13
Device Publish Date2024-06-05

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04260462743969 - Steile Drape for "CONTROL SCREEN"2025-03-26 sterile Monitor and Boards Drape
04260462740371 - Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm2024-06-13 Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm
04260462740951 - HMD cover set, consisting of 2 lens protective caps made of PP, color white2024-06-13 HMD cover set, consisting of 2 lens protective caps made of PP, color white
04260462741255 - PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oran2024-06-13 PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./orange line
04260462742184 - Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm2024-06-13Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm
04260462742184 - Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm2024-06-13 Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm

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