FDA.report

MEDLINE

Primary DI
20197344136015
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDS0181103
Catalog number
MDS0181103
Device description
COMBO,LARYNG,MILLER3,MEDIUM HANDLE
Published
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344136015PackageGS110In Commercial Distribution
10197344136018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734413601520197344136015
1019734413601810197344136018

GMDN Terms

TermDefinition
Microscope slide hybridization/denaturation incubator IVDA mains electricity (AC-powered) laboratory instrument intended to be used for the incubation of microscope slides for the denaturation and/or hybridization of a clinical specimen as part of an in situ hybridization (ISH) and/or fluorescence in situ hybridisation (FISH) protocol. It is typically a bench-top unit with the capacity to hold multiple previously-prepared slides (i.e., fixed slides with/without added reagents) and is programmable to provide an optimum environment for ISH/FISH procedures (e.g., by controlling temperature, humidity and incubation time).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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