FDA.reportPublic FDA data

NA

Primary DI
38032248127402
Brand
NA
Company
DELTA MED SPA
Model
12T7400
Device description
Surgical Drape Kit
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041080000SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.2004-11-30LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38032248127402PackageGS12In Commercial Distribution
08032248127401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803224812740238032248127402
08032248127401080322481274018032248127401

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
444776777
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032248487123AtmosUD-462152025-09-02
08032248487147AtmosUD-A582452025-09-02
08032248487185Infusion SetMMT11732025-09-02
08032248490130AtmosUD-AELN2025-09-02
38032248487124AtmosUD-462152025-09-02
08032248487130AtmosUD-A362052025-09-02
38032248487148AtmosUD-A582452025-09-02
38032248487186Infusion SetMMT11732025-09-02
38032248490131AtmosUD-AELN2025-09-02
08032248471030Securmeter Foley ManometerHM0042025-05-19
38032248471031Securmeter Foley ManometerHM0042025-05-19
08032248127401NA12T74002016-09-23
08032248007123SOL CARE T SIV0012021-03-30
08032248007130SOL CARE T SIV0022021-03-30
08032248007147SOL CARE T SIV0032021-03-30
08032248007154SOL CARE T SIV0042021-03-30
08032248007161SOL CARE T SIV0052021-03-30
08032248007178SOL CARE T SIV0062021-03-30
08032248007185SOL CARE T SIV0072021-03-30
08032248007192SOL CARE T SIV0082021-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
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10198956526525CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
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10198956527652CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527768CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16