FDA.report

TSI

Primary DI
00843059112368
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
ML-0053
Device description
ACMI ADAPTER
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FDGRetractor, Fiberoptic

Product Code Classifications

CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843059112368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843059112368008430591123688430591123680843059112368

GMDN Terms

TermDefinition
Light source adaptorA small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
791619393
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

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00843059127034LattusLAT-15252025-08-26
00843059127041LattusLAT-15262025-08-26
00843059127058LattusLAT-20012025-08-26
00843059127065LattusLAT-20022025-08-26
00843059127072LattusLAT-20032025-08-26
00843059127089LattusLAT-20042025-08-26
00843059127096LattusLAT-20052025-08-26
00843059127102LattusLAT-21402025-08-26
00843059127119LattusLAT-21802025-08-26
00843059127126LattusLAT-22202025-08-26
00843059127133LattusLAT-31402025-08-26
00843059127140LattusLAT-31802025-08-26
00843059127157LattusLAT-32202025-08-26
00843059127171LattusLAT-10062025-07-15
00843059127003TSIUT-07012025-01-30
00843059127010TSIUT-07022025-01-30
00843059127027TSIUT-07032025-01-30
00843059126976TSIML-07152024-11-11

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00812432023195Medtronic 4mm OLYMPUS Cable AdapterLUMITEX, INC.FDG2026-01-07
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