PAJUNK MEDICAL SYSTEMS, LP

Address:4575 Marconi Dr.,Alpharetta,GA,30005,US

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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

Nerve Block Tray (OGJ) (5) Epidural Anesthesia Kit (OGE) (3) Spinal Epidural Anesthesia Kit (OFT) (2)

Premarket Exempt

Clear

NA - 00858965006007 Catalog Number : NA

Device Description : CONTINUOUS EPIDURAL TRAYTuohy Epidural Needle 17G x 4“ withEpiLong Soft Catheter CONTINUOUS EPIDURAL TRAYTuohy Epidural Needle 17G x 4“ withEpiLong Soft Catheter, Closed Tip, 19G

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGE

Prescription Use : Yes

Device Count : 1

NA - 00858965006014 Catalog Number :

Device Description : SINGLE SHOT EPIDURAL TRAYTuohy Epidural Needle 20G x 4“

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGE

Prescription Use : Yes

Device Count : 1

NA - 00858965006021 Catalog Number : NA

Device Description : CONTINUOUS EPIDURAL TRAYTuohy NRFit™ Epidural Needle 17G x 4“ withEpiLong Soft C CONTINUOUS EPIDURAL TRAYTuohy NRFit™ Epidural Needle 17G x 4“ withEpiLong Soft Catheter, Closed Tip, 19G

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGE

Prescription Use : Yes

Device Count : 1

NA - 00858965006083 Catalog Number : NA

Device Description : COMBINED SPINAL EPIDURAL TRAYEpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ withS COMBINED SPINAL EPIDURAL TRAYEpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ withSPROTTE® Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G0.75% Bupivacaine HCl with 8.25% Dextrose

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OFT

Prescription Use : Yes

Device Count : 1

NA - 00858965006090 Catalog Number : NA

Device Description : COMBINED SPINAL EPIDURAL TRAYEpiSpin Tuohy NRFit™ Epidural Needle 17G x 3.5“ wit COMBINED SPINAL EPIDURAL TRAYEpiSpin Tuohy NRFit™ Epidural Needle 17G x 3.5“ withSPROTTE® NRFit Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G0.75% Bupivacaine HCl with 8.25% Dextrose

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OFT

Prescription Use : Yes

Device Count : 1

NA - 00858965006106 Catalog Number : NA

Device Description : SINGLE SHOT NERVE BLOCK TRAYSonoPlex Needle 21G x 4“

Device Class :

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

NA - 00858965006113 Catalog Number : NA

Device Description : SINGLE SHOT NERVE BLOCK TRAYSonoPlex Needle 22G x 2“

Device Class :

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

NA - 00858965006120 Catalog Number : NA

Device Description : CONTINUOUS NERVE BLOCK TRAYE-Cath with Indwelling Catheter 18G x 2“

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

NA - 00858965006137 Catalog Number : NA

Device Description : CONTINUOUS NERVE BLOCK TRAYE-Cath with Indwelling Catheter 18G x 3-1/4“

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

NA - 00858965006144 Catalog Number : NA

Device Description : CONTINUOUS NERVE BLOCK TRAYSonoLong Tuohy Needle 18G x 4“ withSonoLong Echo Cath CONTINUOUS NERVE BLOCK TRAYSonoLong Tuohy Needle 18G x 4“ withSonoLong Echo Catheter, Closed Tip, 20G

Device Class : 2

Duns Number: 136718553

Premarket Exempt : No

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

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