FDA.reportPublic FDA data

SOFT SHIELD® Collagen Shields

Primary DI
10845819005771
Brand
SOFT SHIELD® Collagen Shields
Company
OASIS MEDICAL, INC.
Model
7024
Device description
SOFT SHIELD® Collagen Shield, 24 Hours (CE)
Published
2023-06-30
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
MOECollagen Corneal Shield

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOECollagen Corneal ShieldOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819005771PackageGS110In Commercial Distribution
00845819005774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900577110845819005771
00845819005774008458190057748458190057740845819005774

GMDN Terms#

Term, Definition table
TermDefinition
Epithelial-resurfacing corneal shieldA mechanical eye shield made of an animal-derived biodegradable material (e.g., collagen) intended to be placed on the eye to protect the cornea and permit clinical observation and partial patient vision during postsurgical epithelial resurfacing of the cornea. 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
10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
10845819005474SOFT PLUG® Extended Duration Plugs 5032023-06-30
10845819005498SOFT PLUG® Extended Duration Plugs 5052023-06-30
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
00845819003138Surgeon's Choice CardSCK-2012, B-SCK-20122025-10-02
00845819006375Surgeon's Choice CardSCK 2005, B-SCK 20052023-06-30
00845819020111Surgeon's Choice CardSCK 20112024-11-07
10845819020118Surgeon's Choice CardB-SCK 20112024-11-07
00845819002919Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
00845819002926Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
10845819002916Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
10845819002923Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
00845819002988Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
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
10845819000097SOFT PLUG® Silicone Punctum Plug6610-EP2023-06-30
10845819000110SOFT PLUG® Silicone Punctum Plug6611-EP2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845819005699SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005705SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005774SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005781SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005798SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005696SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005702SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005788SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005795SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00192896109773Cox II H Eye ShieldSONTEC INSTRUMENTS, INC.MOE2021-05-13
00192896109780Cox II H Eye ShieldSONTEC INSTRUMENTS, INC.MOE2021-05-13
00192896103382Eye ShieldSONTEC INSTRUMENTS, INC.MOE2020-07-13
00192896103399Eye ShieldSONTEC INSTRUMENTS, INC.MOE2020-07-13
00192896099999COX II EYE SHIELD SONTEC INSTRUMENTS, INC.MOE2019-11-05
00192896100008COX II EYE SHIELD SONTEC INSTRUMENTS, INC.MOE2019-11-05
00192896095823JAEGER LID PLATESONTEC INSTRUMENTS, INC.MOE2019-03-25
00192896095830SUCTION CUP HANDLESONTEC INSTRUMENTS, INC.MOE2019-03-25
00192896095366COX II H EYE SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095373COX II H EYE SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095250OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095267OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095274OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095281OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095298OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095304OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095311OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095328OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095335OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095342OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896075160EYE SHIELDSONTEC INSTRUMENTS, INC.MOE2018-10-04