SuperBall SBD-SB-12-001

GUDID 00850000630017

The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.

ARCURO MEDICAL LTD

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 ID00850000630017
NIH Device Record Key00dfcce4-f33e-42ff-8394-7bd3ff18ef2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperBall
Version Model NumberB
Catalog NumberSBD-SB-12-001
Company DUNS600664454
Company NameARCURO MEDICAL LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]
GS100850000630017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

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