FDA.reportPublic FDA data

RF Assure

Primary DI
10884521705265
Brand
RF Assure
Company
Covidien LP
Model
01-0027R
Device description
RF Assure Detection System Console Model 200 Refurbished
Published
2025-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWHCounter, sponge, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWHCounter, Sponge, SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521705265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452170526510884521705265

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sponge-counting rackA device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4.5Inch
Length11.75Inch
Weight7Pound
Width9.75Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26
10884521141742Endo GIAEGIARADXT2015-09-01
10884521703728Tri-Staple 2.0SIGCIR28MT2019-06-29
10884521703735Tri-Staple 2.0SIGCIR28XT2024-11-29
10884521703780Tri-Staple 2.0SIGCIR21MT2019-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995243647ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243661ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995245290ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243630ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243654ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243678ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243685ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243692ORLocateSTERIS CORPORATIONLWH2025-04-17
10884521700710SituateCovidien LPLWH2025-04-04
10884521705272SituateCovidien LPLWH2024-06-10
07613327625882SurgiCountSTRYKER CORPORATIONLWH2024-02-12
07613327622751SurgiCountSTRYKER CORPORATIONLWH2024-02-09
07613327622799SurgiCountSTRYKER CORPORATIONLWH2024-02-09
07613327623079SurgiCountSTRYKER CORPORATIONLWH2024-02-09
00724995230050ORLocateSteris CorporationLWH2024-01-31
10884521816770SituateCovidien LPLWH2023-07-09
00810132041532HCSConcordance Healthcare Solutions LLCLWH2023-06-23
10810132041539HCSConcordance Healthcare Solutions LLCLWH2023-06-23
10884521780040SituateCovidien LPLWH2023-03-18
00724995220655ORLocateSteris CorporationLWH2023-03-14
00724995220648ORLocateSteris CorporationLWH2023-03-14
00724995220662ORLocateSteris CorporationLWH2023-03-14
10080196416097MEDLINEMEDLINE INDUSTRIES, INC.LWH2022-12-29
00724995220631ORLocateSteris CorporationLWH2022-12-08
00724995221683ORLocateSteris CorporationLWH2022-12-08
00724995220624ORLocateSteris CorporationLWH2022-12-07
00724995220679ORLocateSteris CorporationLWH2022-12-07
05060356150205ORLocateSteris CorporationLWH2022-11-07
05060356150212ORLocateSteris CorporationLWH2022-11-07
05060356150229ORLocateSteris CorporationLWH2022-11-07