ReSure Sealant

Primary DI
00867968000004
Brand
ReSure Sealant
Company
OCULAR THERAPEUTIX, INC.
Model
5-Up
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PFZOphthalmic Sealant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFZOphthalmic SealantUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130004000RESURE SEALANTOcular Therapeutix, Inc.2014-01-08PFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867968000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867968000004008679680000048679680000040867968000004

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, sterileA sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063391985
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867968000011ReSure Sealant10-Up2014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00867968000011ReSure SealantOCULAR THERAPEUTIX, INC.PFZ2014-09-23