FDA.reportPublic FDA data

Situate

Primary DI
10884521780040
Brand
Situate
Company
Covidien LP
Model
01-0043RS
Device description
Detection Console 200X
Published
2023-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10884521780040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452178004010884521780040

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.5 KiloPascal1.06 KiloPascal
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure0.7 KiloPascal1.06 KiloPascal
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995243630ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995220648ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243654ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243678ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243685ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243692ORLocateSTERIS CORPORATIONLWH2025-04-17
10884521700710SituateCovidien LPLWH2025-04-04
10884521705265RF AssureCovidien LPLWH2025-03-31
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
10810132041539HCSConcordance Healthcare Solutions LLCLWH2023-06-23
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
10884521816787SituateCovidien LPLWH2022-03-11
07613327515855SURGICOUNTSTRYKER CORPORATIONLWH2021-07-08
07613327519518SURGICOUNTSTRYKER CORPORATIONLWH2021-07-08
07613327519525SURGICOUNTSTRYKER CORPORATIONLWH2021-07-08
07613327543094SURGICOUNTSTRYKER CORPORATIONLWH2021-07-08