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 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

17466532979168 - PROteger2025-05-16 Leica Proveo and M800 Series Surgical Protection System 53" X 120" (LP8053120)
17466532979205 - PROteger2025-05-16 Zeiss Resight Shower Cap Drape (ZR3630)
17466532979908 - Sterimed2025-05-16 Video Camera / Laser Arm Cover W/Perf 5” X 96” (VC0596P)
17467423230313 - PROteger2025-05-16 Zeiss MD Microscope Drape, With Flat Lens 53” x 120” (ZF53150)
17467423230320 - PROteger2025-05-16 Zeiss MD Microscope Drape, With Flat Lens 53” x 120” (ZF53120)
27466532979349 - Sterimed2025-05-07 Cysto/Urology Drain Bag Sterile W/ 8mm Adapter For Dornier/Siemens Tables (DB1008-S)
17466532979472 - Sterimed2025-05-07 Handle Cover/Band Bag 9” x 14” (0914)
17466532979489 - Sterimed2025-05-07 Band Bag 36” x 12” (0986)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.