FDA.reportPublic FDA data

Wound Free

Primary DI
00814639024623
Brand
Wound Free
Company
APPLIED DENTAL, INC.
Model
WIV-0607
Catalog number
WIV-0607
Device description
"IV Transparent Film Dressing, 6x7cm (2.375"" x 2.75""). Sterile."
Published
2022-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639024620PackageGS150In Commercial Distribution
00814639024623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902462010814639024620
00814639024623008146390246238146390246230814639024623

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof skin adhesive tapeA long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-888-841-8481info.usa@AD-Surgical.com

Regulatory Flags#

DUNS number
017524666
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814639026856UNIFY Nylon Surgical SuturesXXS-N1012S7DXXS-N1012S7D2026-08-07
00814639026863UNIFY Nylon Surgical SuturesXXS-N1012S5DXXS-N1012S5D2026-08-07
00814639026962Premium UNIFY Fast Gut SuturesPXSRJ-618R11PXSRJ-618R112026-08-07
00814639026979Premium UNIFY Plain Gut SuturesPXSJ-618R11PXSJ-618R112026-08-07
00814639026993Premium UNIFY Plain Gut SuturesPXSJ-618R11DPXSJ-618R11D2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesPSJ-518R13DPSJ-518R13D2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesPSJ-418K13PSJ-418K132026-08-07
00814639027020Premium UNIFY Chromic SuturesPSC-518R13DPSC-518R13D2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesPXSC-618R11PXSC-618R112026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesPXSC-618R11DPXSC-618R11D2026-08-07
00814639027051Premium UNIFY Chromic SuturesPSC-418R13DPSC-418R13D2026-08-07
00814639025606UNIFY PGA Surgical SuturesS-G518XR13-U2026-07-17
00814639025781UNIFY PGA Surgical SuturesS-G518XR13-U2023-04-12
00814639023374SUPERFITA520-LTX602020-08-06
00814639023381SUPERFITA520-LTX652020-08-06
00814639023398SUPERFITA520-LTX702020-08-06
00814639023404SUPERFITA520-LTX752020-08-06
00814639023411SUPERFITA520-LTX802020-08-06
00814639026832UNIFY MicroSutures SilkXXS-S618S6DXXS-S618S6D2026-04-27
00814639026849UNIFY MicroSutures SilkXS-S618R11DXS-S618R11D2026-04-27

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