FDA.reportPublic FDA data

DeScribe Transparent PFD Patch

Primary DI
00186295000342
Brand
DeScribe Transparent PFD Patch
Company
MERZ NORTH AMERICA, INC.
Model
5035838
Device description
Individually packaged DeScribe PFD Patch (each)Contains 5 DeScribe PFD Patches.
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
00186295000342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00186295000342001862950003421862950003420186295000342

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
00186295000359DeScribe Transparent PFD PatchMERZ NORTH AMERICA, INC.PKO2017-02-06
00864525000200DeScribe Transparent PFD PatchOn Light Sciences, Inc.PKO2016-09-24