DAS Medical SPD-18-001

GUDID 17466532979038

Lateral and Prone Access Drape (SPD-18-001)

DAS Medical International SRL

Patient surgical drape, single-use, sterile
Primary Device ID17466532979038
NIH Device Record Keyf1d6e122-6fb9-4413-9b13-791fba651287
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAS Medical
Version Model NumberSPD-18-001
Catalog NumberSPD-18-001
Company DUNS817435655
Company NameDAS Medical International SRL
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX
Phone809-556-8900
EmailXX@XX.XX

Device Identifiers

Device Issuing AgencyDevice ID
GS117466532979038 [Package]
Contains: 74665329790312
Package: Carton [2 Units]
In Commercial Distribution
GS174665329790312 [Primary]

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


[17466532979038]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2018-02-23

Devices Manufactured by DAS Medical International SRL

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17466532979243 - Asensus2021-05-18 Senhance USB-C LIA Drape (X9007763)
17466532979113 - Schaerer2021-05-11 Urology Drain Bag
17466532979137 - Schaerer2021-05-11 Patient Isolation Drape
17466532979144 - Proteger2021-05-11 Zeiss 65D Surgical Protection System 53" X 120" (ZP6553120)
17466532979175 - Proteger2021-05-11 Leica 68D Surgical Protection System 53" X 120" (LP6853120)
17466532979229 - Rampart2021-04-15 Rampart OUS Drape Kit
07466532979017 - TransEnterix2021-03-29 Senhance Manipulator Drape 1-PK X9007635

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