FDA.reportPublic FDA data

3M™ Tegaderm™

Primary DI
50707387455656
Brand
3M™ Tegaderm™
Company
3M COMPANY
Model
9545HP
Catalog number
9545HP
Device description
9545HP TRANSPARENT DRSG W/FRAME
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
50707387455656PackageGS16In Commercial Distribution
04001895928826PrimaryGS10
00707387455651Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738745565650707387455656
04001895928826040018959288264001895928826
00707387455651007073874556517073874556510707387455651

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
50
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007073874985353M™ Cavilon™3344E3344E2022-12-08
007073877918893M™ Cavilon™3344ENS3344ENS2022-12-08
10608223630003Bair Hugger™63000630002016-09-24
10608223645007Bair Hugger™64500645002016-09-24
507073878140263M™ Ioban™8840EZ8840EZ2025-01-17
507073878140333M™ Ioban™8850EZ8850EZ2025-01-17
307073878140463M™ Ioban™8851EZ8851EZ2025-01-17
507073878140573M™ Ioban™8840EZSB8840EZSB2025-01-17
507073878140643M™ Ioban™8850EZSB8850EZSB2025-01-17
507073878140713M™ Ioban™8851EZSB8851EZSB2025-01-17
507073875674653M™861186112026-02-19
507073877738733M™861086102026-02-19
506058610858733M™6550A16550A12025-09-09
506058610858803M™6550A26550A22025-09-09
506058610858973M™6550A36550A32025-09-09
506058610859033M™6550A3.56550A3.52025-09-09
506058610859103M™6550A46550A42025-09-09
506058610859273M™6550B16550B12025-09-09
506058610859343M™6550B26550B22025-09-09
506058610859413M™6550D36550D32025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479282179McKessonMCKESSON MEDICAL-SURGICAL INC.NAD2026-03-17
06974795053920MEDLOTHenan Maidingkang Medical Technology Co., Ltd.NAD2026-03-13
30885632495469HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495851HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495875HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496742HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
06974843740574MemGardDalian Orientech Co.,LtdNAD2026-03-10
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06974843740857MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740864MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740871MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740888MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740895MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740901MemGardDalian Orientech Co.,LtdNAD2026-03-10