DAS SPD-18-001

GUDID 07466532979031

Lateral and Prone Access Drape SPD-18-001

DAS Medical International SRL

Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use
Primary Device ID07466532979031
NIH Device Record Key43f46732-481b-4779-b53e-00a5f3e62e1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAS
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
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
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
GS107466532979031 [Primary]
GS117466532979038 [Package]
Package: Case [2 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

[07466532979031]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-29
Device Publish Date2021-03-19

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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