FDA.reportPublic FDA data

TIELLE® PACKING

Primary DI
15051978000532
Brand
TIELLE® PACKING
Company
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Model
MT2450
Catalog number
MT2450
Device description
Hydropolymer Dressing
Published
2019-09-24
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
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
25051978000539PackageGS110In Commercial Distribution
15051978000532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505197800053925051978000539
1505197800053215051978000532

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, non-antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9.5Centimeter
Width9.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
211352227
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051978001089FIBRACOL® PLUS298129812019-09-24
15051978001096FIBRACOL® PLUS298229822019-09-24
15051978001102FIBRACOL® PLUS298329832019-09-24
15051978001119FIBRACOL® PLUS298429842019-09-24
15051978002833PROMOGRAN PRISMA®MA028MA0282019-09-24
15051978002888PROMOGRAN PRISMA®MA123MA1232019-09-24
15051978003083PROMOGRAN®PG004PG0042019-09-24
15051978003090PROMOGRAN®PG019PG0192019-09-24
15051978009993PROMOGRAN PRISMA®MA032MA0322019-09-24
15051978003427DYNA-FLEX™70252018-09-24
15051978006428BIOCLUSIVE® PLUSBIP0607BIP06072019-09-24
15051978006435BIOCLUSIVE® PLUSBIP1012BIP10122019-09-24
15051978006442BIOCLUSIVE® PLUSBIP1520BIP15202019-09-24
15051978006459BIOCLUSIVE® PLUSBIP2030BIP20302019-09-24
15051978002543NU-DERM® HCB102HCB1022019-09-24
15051978002550NU-DERM® HCB106HCB1062019-09-24
15051978002567NU-DERM® HCS100HCS1002019-09-24
15051978002574NU-DERM®HCT101HCT1012019-09-24
15051978002581NU-DERM® HCB108HCB1082019-09-24
15051978002604NU-DERM® HCB204HCB2042019-09-24

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