FDA.reportPublic FDA data

Surgical Marking Pen

Primary DI
10845819000479
Brand
Surgical Marking Pen
Company
OASIS MEDICAL, INC.
Model
0442
Device description
Surgical Marking Pen, Fine Tip, Gentian Violet.
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
10845819000479PackageGS110In Commercial Distribution
00845819000472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900047910845819000479
00845819000472008458190004728458190004720845819000472

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
9093055400customerservice@oasismedical.com

Regulatory Flags#

DUNS number
194121018
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
true
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
00845819020111Surgeon's Choice CardSCK 20112024-11-07
10845819020118Surgeon's Choice CardB-SCK 20112024-11-07
10845819002916Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
10845819002923Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
00845819002971Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
10845819002985Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002322Premier Edge® Microsurgical KnivesPE4827-TL, B-PE4827-TL2023-04-30
00845819000267SOFT PLUG® Extended Duration Plugs 6400V2023-07-31
10845819000219SOFT PLUG® Extended Duration Plugs 6402, 6402-A2023-07-31
10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
10845819000080SOFT PLUG® Silicone Punctum Plug6610-S, 6610, 6610-D2023-06-30
10845819000103SOFT PLUG® Silicone Punctum Plug6611-S, 6611, 6611-D2023-06-30
00845819000120SOFT PLUG® Silicone Punctum Plug6612-S, 6612, 6612-D2023-06-30
10845819000141SOFT PLUG® Silicone Punctum Plug6612-SFC, 6612-FC2023-06-30
10845819000172SOFT PLUG® Silicone Punctum Plug6613-S, 6613, 6613-D2023-06-30
10845819000202SOFT PLUG® Silicone Punctum Plug6614-S, 6614, 6614-D2023-06-30
10845819000226SOFT PLUG® Silicone Punctum Plug6614-SFC, 6614-FC2023-06-30
10845819000271FORM FIT® Hydrogel Canalicular Plug6303, 6303-T, B-63032023-06-30
10845819000318Lacrimal lntubation Set60042023-06-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G42520103680My MedicalMy Medical Store LLCFZZ2026-02-26
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26931918101047AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918108411AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918152353AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918161324AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918172931AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
07540277010041RMAC SurgicalRMAC Surgical, IncFZZ2026-01-06
00860012465019FungalBlueToeFX IncFZZ2025-12-03
00194613019075MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
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00194613123277MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123291MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
G2231523360Medetz Surgical InstrumentsMedetz Surgical Instruments LLCFZZ2025-06-30
10714646001129Sample: Opti-TattBionix, LLCFZZ2025-06-20
40080196771852MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389025940MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389711799MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12