Rotium Bioresorbable Wick

GUDID 20852513007052

NANOFIBER SOLUTIONS, INC.

Tendon/ligament bone anchor, bioabsorbable

Primary Device ID	20852513007052
NIH Device Record Key	94a003a2-e96e-496a-b040-f1ec8c5948d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rotium Bioresorbable Wick
Version Model Number	FG-0007
Company DUNS	830384223
Company Name	NANOFIBER SOLUTIONS, INC.
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	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter
Width	2 Centimeter
Length	2 Centimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852513007058 [Primary]
GS1	10852513007055 [Package] Contains: 00852513007058 Package: Shelf Box [1 Units] In Commercial Distribution
GS1	20852513007052 [Package] Contains: 10852513007055 Package: Case [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183236

FDA Product Code

MAI	Fastener, Fixation, Biodegradable, Soft Tissue

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	2019-04-11
Device Publish Date	2019-04-03

On-Brand Devices [Rotium Bioresorbable Wick]

20852513007052	FG-0007
00852513007317	FG-0043