FDA.reportPublic FDA data

ITL Essentials™ Needle Mat (Sterile)

Primary DI
19555240401080
Brand
ITL Essentials™ Needle Mat (Sterile)
Company
ITL ASIA PACIFIC SDN. BHD.
Model
A500101
Catalog number
A500101
Device description
ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporarily storing used sharps (suture needles and blades) in the surgical suite.
Published
2020-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19555240401097PackageGS16Not in Commercial Distribution
19555240401370PackageGS116Not in Commercial Distribution
19555240401080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1955524040109719555240401097
1955524040137019555240401370
1955524040108019555240401080

GMDN Terms#

Term, Definition table
TermDefinition
Sharp surgical instrument counting tray/pad, single-useA device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Direct Sunlight
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+18884112851sales@itlbiomedical.com

Regulatory Flags#

DUNS number
597723837
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09555240404992SCU Narrow Cap SamplerA100724A1007242025-06-04
09555240405616SampLok® Sampling Kit 16mLA100756A1007562025-06-04
19555240404999SCU Narrow Cap SamplerA100724A1007242025-06-04
19555240405613SampLok® Sampling Kit 16mLA100756A1007562025-06-04
09555240400536SampLok® Sampling Kit 16mLA100740A1007402019-03-29
09555240400734SampLok® Sampling Kit 10mLA100750A1007502019-03-29
09555240403865SampLok® Sampling Kit 35mLA100752A1007522019-08-21
09555240404084SampLok® Sampling Kit 20mLA100754A1007542020-02-29
09555240405593SCU Narrow Cap Sampler Syringe KitA100727A1007272025-04-21
19555240401110Safety SubCulture Unit (SCU)A100720A1007202020-09-19
19555240401400Transfer Cap SetA100730A1007302020-02-29
19555240401431Safety SubCulture Unit 2 (SCU2)A100722A1007222020-09-19
09555240404985SCU Wide Cap SamplerA100723A1007232024-12-11
19555240405590SCU Narrow Cap Sampler Syringe KitA100727A1007272025-04-21
09555240401304SampLok® Adapter Cap 2A100718A1007182019-03-29
09555240401540SampLok® Adapter Cap 3A100762A1007622019-03-29
09555240401557SampLok® Adapter Cap 3 InsertA100763A1007632019-03-29
19555240400014SampLok® Adapter Cap InsertA100709A1007092019-03-29
19555240401219SampLok® Adapter Cap 2A100715A1007152019-03-29
19555240404098ITL Essentials™ Tourniquet B&B Thick Strap 45cm NSA600001A6000012023-12-11

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