FDA.reportPublic FDA data

TESA IF Screw System

Primary DI
00850075235063
Brand
TESA IF Screw System
Company
Tesa Medical, Inc.
Model
90-TSA-000100
Catalog number
90-TSA-000100
Device description
TESA IF Screw Instrument Tray
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00850075235063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075235063008500752350638500752350630850075235063

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
145004472
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850075235070TESA Tensioner System90-TSA-00020090-TSA-0002002026-05-26
00850075235087TESA IF Screw System90-TSA-15001090-TSA-1500102026-05-26
00850075235094TESA IF Screw System90-TSA-15001590-TSA-1500152026-05-26
00850075235100TESA IF Screw System90-TSA-15011590-TSA-1501152026-05-26
00850075235117TESA IF Screw System90-TSA-15061090-TSA-1506102026-05-26
00850075235124TESA IF Screw System90-TSA-15062090-TSA-1506202026-05-26
00850075235131TESA Tensioner System90-TSA-31300090-TSA-3130002026-05-26
00850075235148TESA Tensioner System90-TSA-33200190-TSA-3320012026-05-26
00850075235155TESA Tensioner System90-TSA-33305090-TSA-3330502026-05-26
00850075235162TESA Tensioner System90-TSA-33307090-TSA-3330702026-05-26
00850075235179TESA Tensioner System90-TSA-00025090-TSA-0002502026-05-26

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