TranEnterix X0008236

GUDID 07466532979048

Sterile Tape X0008236

DAS Medical International SRL

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use
Primary Device ID07466532979048
NIH Device Record Key3412e2ef-05f6-48e3-afc0-1524d1332910
Commercial Distribution StatusIn Commercial Distribution
Brand NameTranEnterix
Version Model NumberX0008236
Catalog NumberX0008236
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107466532979048 [Primary]
GS117466532979045 [Package]
Package: Inner Box [20 Units]
In Commercial Distribution
GS127466532979042 [Package]
Contains: 17466532979045
Package: Case [3 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

Ethylene Oxide

[07466532979048]

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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