Aztecmed/Ent LLC

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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

Holder, Needle, Gastroenterologic (FHQ) (4) Speculum, Ent (EPY) (4) Forceps, General & Plastic Surgery (GEN) (1) Scissors, General, Surgical (LRW) (1)

Premarket Exempt

Yes

Clear

Aztec - B87111156220 Catalog Number : 11-15622

Device Description : Klinik Hemostatic Forcep straight

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

Aztec - B87111157020 Catalog Number : 11-15702

Device Description : Klinik Webster Needle Holder smooth

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Aztec - B87111157030 Catalog Number : 11-15703

Device Description : Klinik Webster Needle Holder serrated

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Aztec - B87111157500 Catalog Number : 11-15750

Device Description : Klinik Olsen Hegar Needle Holder

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Aztec - B87111157600 Catalog Number : 11-15760

Device Description : Klinik Mayo Hegar Needle Holder

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Aztec - B87111201090 Catalog Number : 11-20109

Device Description : Klinik Nasal Speculum Infant

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

Aztec - B87111201100 Catalog Number : 11-20110

Device Description : Klinik Nasal Speculum Small

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

Aztec - B87111201200 Catalog Number : 11-20120

Device Description : Klinik Nasal Speculum Medium

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

Aztec - B87111201300 Catalog Number : 11-20130

Device Description : Klinik Nasal Speculum Large

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

Aztec - B87111242000 Catalog Number : 11-24200

Device Description : Klinik Lister Bandage Scissor

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : No

Device Count : 1

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