FDA.report

mytaMed

Primary DI
B351660010
Brand
mytaMed
Company
Mytamed, Inc.
Model
6.60.01
Catalog number
6.60.01
Device description
Farrel Applicator, Round, 14cm, 0.9mm
Published
2018-02-15
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
KCJApplicator, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B351660010PrimaryHIBCC0

GMDN Terms

TermDefinition
Cotton pledget applicator, single-useA slender rod of wood, flexible metal, or synthetic material with a pledget of cotton attached at one end intended to be used for cleaning or applying a substance (e.g., medication) to superficial wounds or body orifices [e.g., ears, nose, oral cavity, throat, anus, rectum]. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
015903922
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
false
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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B351B706300BEAR7.06.307.06.302020-05-12
B351B706310BEAR7.06.317.06.312020-05-12
B351B706320BEAR7.06.327.06.322020-05-12
B351B706340BEAR7.06.347.06.342020-05-12
B351B707260BEAR7.07.267.07.262020-05-12
B351B810100BEAR8.10.108.10.102020-05-19
B351B707270BEAR7.07.277.07.272020-05-12
B351B707290BEAR7.07.297.07.292020-05-12
B351B707300BEAR7.07.307.07.302020-05-12
B351B810050BEAR8.10.058.10.052020-05-19
B351B810060BEAR8.10.068.10.062020-05-19
B351B810070BEAR8.10.078.10.072020-05-19

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00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry Surgical®SYMMETRY SURGICAL INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze BestKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
00842331192524Novo Surgical Inc. NOVO SURGICAL, INC.KCJ2023-12-07
25060259070420Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
45060259070486Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070857DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
55060259070988DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
55060259070995DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
15060259073127DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259073131DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
00705928002043NeilMed Sinus RinseNEILMED PHARMACEUTICALS, INC.KCJ2023-03-02
00705928003002NeilMed Sinus RinseNEILMED PHARMACEUTICALS, INC.KCJ2023-03-02
00705928003101Sinus Rinse KitNEILMED PHARMACEUTICALS, INC.KCJ2023-03-02