SUPOLENE

GUDID E203US90616

Resorba Medical GmbH

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament

Primary Device ID	E203US90616
NIH Device Record Key	80afeae1-66aa-44b1-970c-78b5eda16538
Commercial Distribution Status	In Commercial Distribution
Brand Name	SUPOLENE
Version Model Number	SUPOLENE
Company DUNS	341053195
Company Name	Resorba Medical GmbH
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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E203US90616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K143582

FDA Product Code

GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-04-08
Device Publish Date	2019-02-03

On-Brand Devices [SUPOLENE]

E203USSW655	SUPOLENE
E203USSW5105	SUPOLENE
E203USM90613	SUPOLENE
E203US9158	SUPOLENE
E203US9157	SUPOLENE
E203US9156	SUPOLENE
E203US9155	SUPOLENE
E203US91526	SUPOLENE
E203US9152	SUPOLENE
E203US91514	SUPOLENE
E203US9148	SUPOLENE
E203US91426	SUPOLENE
E203US9132	SUPOLENE
E203US90616	SUPOLENE
E203US9038	SUPOLENE
E203US9028	SUPOLENE
E203US9027	SUPOLENE
E203US9026	SUPOLENE
E203US90231	SUPOLENE
E203US90230	SUPOLENE
E203US90225	SUPOLENE
E203US90223	SUPOLENE
E203US90220	SUPOLENE
E203US90219	SUPOLENE
E203US90214	SUPOLENE
E203US90210	SUPOLENE

Trademark Results [SUPOLENE]

Mark Image Registration \| Serial	Company Trademark Application Date
SUPOLENE 79197727 5184140 Live/Registered	Resorba Medical GmbH 2016-06-06