Demetech PTFE

GUDID 30652927695831

Synthetic (Polytetrafluoroethylene), Non Absorbable Suture

DEMETECH CORPORATION

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament

Primary Device ID	30652927695831
NIH Device Record Key	030c64e5-9076-4406-9406-c3dd2ef01e23
Commercial Distribution Status	In Commercial Distribution
Brand Name	Demetech PTFE
Version Model Number	TE654013B0P
Company DUNS	039436691
Company Name	DEMETECH CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	true
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us
Phone	3058241048
Email	info@demetech.us

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10652927695837 [Primary]
GS1	30652927695831 [Package] Contains: 10652927695837 Package: [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181578

FDA Product Code

NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-01-23
Device Publish Date	2020-01-15

On-Brand Devices [Demetech PTFE]

30652927432580	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927667791	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927667784	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927667432	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927667425	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671712	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671705	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671699	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671682	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671675	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671668	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671651	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671644	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671637	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671620	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671613	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671606	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671590	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671583	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671576	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671569	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671552	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671545	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671538	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671521	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671514	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671507	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671491	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671484	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671477	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671460	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671453	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671446	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671439	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671422	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671415	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671408	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671392	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671385	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671378	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671361	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671354	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671347	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671330	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671323	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671316	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671309	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671293	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671286	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
30652927671279	Synthetic (Polytetrafluoroethylene), Non Absorbable Suture