FDA.reportPublic FDA data

NA

Primary DI
08032248127401
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
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 surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
444776777
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
08032248007208SOL CARE T SIV0092021-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233017276Busse Hospital DisposablesROBERT BUSSE & CO., INC.LRO2026-05-28
10809160522059HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522073HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522080HalyardAVID MEDICAL, INC.LRO2026-05-28
10885632522079SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-28
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
10653160393757CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-05-27
10809160521878HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521885HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521892HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521922HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521939HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521946HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521953HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521960HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521977HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521991HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522004HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522011HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522028HalyardAVID MEDICAL, INC.LRO2026-05-27
H65857028265Henry ScheinHENRY SCHEIN, INC.LRO2022-01-28
H65857028255Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028285Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028925Henry ScheinHENRY SCHEIN, INC.LRO2022-01-26
H65857028935Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028915Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028905Henry ScheinHENRY SCHEIN, INC.LRO2022-01-18
H65857028875Henry ScheinHENRY SCHEIN, INC.LRO2021-12-29
H65857028865Henry ScheinHENRY SCHEIN, INC.LRO2021-12-21
H65857028855Henry ScheinHENRY SCHEIN, INC.LRO2021-12-14