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Tensile Tape

FDA UDI

Class II (US FDA UDI)

by Dunamis Medical LLC

Identity

Trade Name
Tensile Tape FDA UDI
Generic Name
Polyolefin/fluoropolymer suture, multifilament FDA UDI
Device Name
1.5mm Blue 38" Tensile Tape FDA UDI
Model / Reference
DFX0031S FDA UDI
Description
1.5mm Blue 38" Tensile Tape FDA UDI

Identifiers

Catalog Number
DFX0031S FDA UDI
Primary DI / UDI-DI
00854629006666 FDA UDI
510(k) Number
K153746 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Polyolefin/fluoropolymer suture, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilament

Tensile Tape by Dunamis Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, multifilament.

Cleared under the same submission

K153746 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dunamis Medical LLC

Sources (1)

  • FDA UDI fb511061-8a99-4ef9-affa-a99139d5e57d 36 fields · synced May 31, 2026