GUDID 38032248127402

Surgical Drape Kit

DELTA MED SPA

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID38032248127402
NIH Device Record Keyc52cfcd0-2cd7-4019-b7f9-86f9b7c9fe0e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number12T7400
Company DUNS444776777
Company NameDELTA MED SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108032248127401 [Primary]
GS138032248127402 [Package]
Contains: 08032248127401
Package: Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-11-06
Device Publish Date2016-09-23

Devices Manufactured by DELTA MED SPA

38032248487124 - Atmos2025-09-10 Pump Tubing 4x6 mm
08032248487130 - Atmos2025-09-10 Pump Tubing 3,2 x 6,4
38032248487148 - Atmos2025-09-10 Pump Tubing 5x8mm
38032248487186 - Infusion Set2025-09-10 Pump Tubing 4x6mm
38032248490131 - Atmos2025-09-10 Transparent Extension Line 1500mm
38032248471031 - Securmeter Foley Manometer2025-05-27 Inta-abdominal pressure measuring system
38032248007124 - SOL CARE T 2021-04-07 I.V. Catheter with protector
38032248007131 - SOL CARE T 2021-04-07 I.V. Catheter with protector

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