FDA.reportPublic FDA data

Anmuth Medical International

Primary DI
08403207009340
Brand
Anmuth Medical International
Company
Anmuth Medical International, LLC
Model
72-181-16
Catalog number
72-181-16
Device description
"Pitanguy Flap Demarcator small, 5.0 mm wide, 6-1/4"" (15.9 cm)"
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZZMARKER, SKIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08403207009340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08403207009340084032070093408403207009340

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, single-useA manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.25Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(413)478-9876marc@anmuthmedical.com

Regulatory Flags#

DUNS number
786500830
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08403207010032Anmuth Medical International39-539-0339-539-032025-06-09
08403207009500Anmuth Medical International39-110-0039-110-002025-06-09
08403207009517Anmuth Medical International39-112-0039-112-002025-06-09
08403207009524Anmuth Medical International39-138-0039-138-002025-06-09
08403207009579Anmuth Medical International39-172-0039-172-002025-06-09
08403207009647Anmuth Medical International39-311-2039-311-202025-06-09
08403207009807Anmuth Medical International39-525-0639-525-062025-06-09
08403207010162Anmuth Medical International39-546-54TC39-546-54TC2025-06-09
08403207010179Anmuth Medical International39-547-24TC39-547-24TC2025-06-09
08403207010261Anmuth Medical International39-557-2539-557-252025-06-09
08403207010278Anmuth Medical International39-559-40TC39-559-40TC2025-06-09
08403207010285Anmuth Medical International39-559-47TC39-559-47TC2025-06-09
08403207010292Anmuth Medical International39-560-57TC39-560-57TC2025-06-09
08403207010346Anmuth Medical International39-630-0039-630-002025-06-09
08403207010353Anmuth Medical International39-633-2039-633-202025-06-09
08403207010360Anmuth Medical International39-635-1739-635-172025-06-09
08403207010377Anmuth Medical International39-650-2339-650-232025-06-09
08403207010384Anmuth Medical International39-666-0639-666-062025-06-09
08403207009531Anmuth Medical International39-160-0039-160-002025-06-05
08403207009548Anmuth Medical International39-161-1339-161-132025-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16931918172934AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
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00630094177267Bioseal Inc.BIOSEALFZZ2023-10-03
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