DAS SPD-18-001

GUDID 07466532979031

Lateral and Prone Access Drape SPD-18-001

DAS Medical International SRL

Patient surgical drape, single-use

Primary Device ID	07466532979031
NIH Device Record Key	43f46732-481b-4779-b53e-00a5f3e62e1c
Commercial Distribution Status	In Commercial Distribution
Brand Name	DAS
Version Model Number	SPD-18-001
Catalog Number	SPD-18-001
Company DUNS	817435655
Company Name	DAS Medical International SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX
Phone	809-556-8900
Email	XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	07466532979031 [Primary]
GS1	17466532979038 [Package] Package: Case [2 Units] In Commercial Distribution

FDA Product Code

PUI	Drape, Surgical, Exempt

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[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 Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-29
Device Publish Date	2021-03-19

Devices Manufactured by DAS Medical International SRL

17466532979236 - Asensus	2021-05-18 Senhance Articulating Drape (X9007762)
17466532979243 - Asensus	2021-05-18 Senhance USB-C LIA Drape (X9007763)
17466532979113 - Schaerer	2021-05-11 Urology Drain Bag
17466532979137 - Schaerer	2021-05-11 Patient Isolation Drape
17466532979144 - Proteger	2021-05-11 Zeiss 65D Surgical Protection System 53" X 120" (ZP6553120)
17466532979175 - Proteger	2021-05-11 Leica 68D Surgical Protection System 53" X 120" (LP6853120)
17466532979229 - Rampart	2021-04-15 Rampart OUS Drape Kit
07466532979017 - TransEnterix	2021-03-29 Senhance Manipulator Drape 1-PK X9007635