FDA.reportPublic FDA data

Kendall

Primary DI
30884527018721
Brand
Kendall
Company
Cardinal Health, Inc.
Model
41533
Catalog number
41533
Device description
Vaginal Prep Pack
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GECBRUSH, SCRUB, OPERATING-ROOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GECBrush, Scrub, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884527018721PackageGS120In Commercial Distribution
20884527018724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452701872130884527018721
2088452701872420884527018724

GMDN Terms#

Term, Definition table
TermDefinition
Surgical scrub preparation kitA collection of sterile devices designed for preoperative preparation of surgical personnel, e.g., scrubbing the fingers, hands and forearms, prior to gloving and donning surgical apparel. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10620974004551Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974004568Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974001338Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004506Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004513Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004520Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004537Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004322Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004339Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004346Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004353Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004360Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
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10620974004384Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004391Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004325Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004332Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004349Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004356Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004363Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004370Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004387Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004394Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00194613045883MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613115708MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613116101MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613116118MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
0066641611231980000 Series Reusable General and Rigid Cleaning BrushPrimed Instruments IncGEC2025-06-13