FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425282814
Brand
CARDINAL HEALTH
Company
CARDINAL HEALTH 200, LLC
Model
SID29DRCCA
Catalog number
SID29DRCCA
Device description
STRL DAVINCI RBT CVR DRAPE PK
Published
2016-07-27
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
PAAAutomated breast ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAAAutomated Breast UltrasoundUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425282812PackageGS18In Commercial Distribution
10885425282814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542528281250885425282812
1088542528281410885425282814

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
112164780
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278756138InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-12
00195278756237InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-04
10197106527344CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
50197106527342CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
10197106530061CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
50197106530069CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
10197106493168CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
50197106493166CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
10197106471609CARDINAL HEALTHCardinal Health 200, LLCPAA2023-10-05
50197106471607CARDINAL HEALTHCardinal Health 200, LLCPAA2023-10-05
10197106038543CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
50197106038541CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
10197106192573CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
50197106192571CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
00860000221306SoftVueDelphinus Medical Technologies, IncPAA2022-12-07
10195594787271CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
50195594787279CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
10195594783907CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
50195594783905CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
00840682141161InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2018-09-04
50885425282812CARDINAL HEALTHCardinal Health 200, LLCPAA2016-07-27
00840682100090InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2016-01-29
00840682100014InveniaGE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLCPAA2014-09-24
00840682100021InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24
00840682100038InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24