FIGURE 8 SURGICAL, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cerclage, Fixation (JDQ) (6)

Premarket Exempt

Clear

Figure 8 Sternotomy Closure Device - 00862376000301 Catalog Number : FP-20155

Device Class : 2

Duns Number: 078582803

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

Figure 8 Sternotomy Closure Device - 00862376000325 Catalog Number :

Device Description : Single Straps Packaged Assembly

Device Class : 2

Duns Number: 078582803

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

Figure 8 Sternotomy Closure Device - 00862376000332 Catalog Number :

Device Description : Double Straps Packaged Assembly

Device Class : 2

Duns Number: 078582803

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

Figure 8 Sternotomy Closure Device - 00862376000349 Catalog Number :

Device Description : Sternotomy Closure Device (Shipper)

Device Class : 2

Duns Number: 078582803

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

Figure 8 Sternotomy Closure Device - 10862376000322 Catalog Number :

Device Description : Shelf Box for Single Straps

Device Class : 2

Duns Number: 078582803

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

Figure 8 Sternotomy Closure Device - 10862376000339 Catalog Number :

Device Description : Shelf Box for Double Straps

Device Class : 2

Duns Number: 078582803

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

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