FDA.reportPublic FDA data

TIELLE®

Primary DI
25051978000607
Brand
TIELLE®
Company
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Model
MTL103
Catalog number
MTL103
Device description
Hydropolymer Adhesive Dressing
Published
2019-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
25051978000607PackageGS15In Commercial Distribution
15051978000600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505197800060725051978000607
1505197800060015051978000600

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gelA sterile wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Centimeter
Width18Centimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211352227
Device count
1
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
false
Sterilization required before use
false

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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Primary DI, Brand, Company table
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10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
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10840330701607ProCureTwin Med, LLCNAD2026-04-28
10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
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10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
00324357200457Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
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10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21