FDA.reportPublic FDA data

DeScribe Transparent PFD Patch

Primary DI
00186295000359
Brand
DeScribe Transparent PFD Patch
Company
MERZ NORTH AMERICA, INC.
Model
5035837
Device description
Individually packaged DeScribe PFD Patch (each)
Published
2017-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKOTransparent Patch For Use In Treatment Of Tattoos

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKOTransparent Patch For Use In Treatment Of TattoosGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00186295000335PackageGS110In Commercial Distribution
00186295000359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00186295000335001862950003351862950003350186295000335
00186295000359001862950003591862950003590186295000359

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesive, non-sterileA non-sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to skin typically intended to fix a primary dressing or a medical device (e.g. drainage tube), or to provide protection from fluids. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-862-1211mymerzsolutions@merz.com

Regulatory Flags#

DUNS number
028147846
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810235030860US Accessory Kit8070M02026-03-05
00810235030877US Rigid Needle with Support Cannula- Double Bevel9010M02026-03-05
00810235030884US Rigid Injection Needle with Huber Point9001M02026-03-05
00810235030846Prolaryn Gel 1.0 cc2026-02-24
00810235030853Prolaryn Plus1.0 cc2026-02-24
10810235030638"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"9012M02024-10-21
10810235030645Coaptite8005M02024-10-15
M2138700M05Belotero Balance8700M02014-09-17
M2139022M1X205"K-Pack II Needle 27 GA x 0.75"" T.W. (0,4 x 20mm)"9022M1X202022-12-08
08714729804796Coaptite8005P10M00689030002014-09-17
M2138044M0K55Prolaryn Plus Injectable Implant8044M0K52015-10-28
M2138063M0K15Radiesse (+) Lidocaine1.5cc Injectable Implant8063M0K12015-08-19
M2138063M0K25Radiesse (+) Lidocaine8063M0K22016-09-09
M2138067M0K15Radiesse (+) Lidocaine 0.8cc Injectable Implant8067M0K12015-08-19
M2138069M0K15Radiesse Moderate Fill 0.8cc8069M0K12014-09-17
M2138071C0K15Radiesse Volume Advantage 1.5cc8071C0K12016-03-30
M2138071M0H15Radiesse Injectable Implant1.5cc8071M0H12016-06-24
M2138071M0K15Radiesse Volume Advantage 1.5cc8071M0K12014-09-17
M2138071M0K25Radiesse Volume Advantage8071M0K22016-09-09
M2138602M0K55Prolaryn Gel Injectable Implant8602M0K52015-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00186295000366DeScribe Transparent PFD PatchMERZ NORTH AMERICA, INC.PKO2017-04-13
00186295000342DeScribe Transparent PFD PatchMERZ NORTH AMERICA, INC.PKO2017-02-06
00864525000200DeScribe Transparent PFD PatchOn Light Sciences, Inc.PKO2016-09-24