KEYSTONE MANUFACTURING, LLC

Address:6387 Technology Ave Ste B,Kalamazoo,MI,49009,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

Applicator, Absorbent Tipped, Sterile (KXG) (4) Lock, Wire, And Ligature, Intraoral (DYX) (4) Container, Specimen Mailer And Storage, Sterile (KDT) (2)

Premarket Exempt

No Yes

Clear

MINNE TIES MT-1000 - 00860000906005 Catalog Number :

Device Description : Maxilla-Mandibular Fixation (MMF) Suture System

Device Class : 2

Duns Number: 013799942

Premarket Exempt : No

Product Code : DYX

Prescription Use : No

Device Count : 1

MINNE TIES MT-1001 - 00860000906012 Catalog Number :

Device Description : Maxilla-Mandibular Fixation (MMF) Suture System

Device Class : 2

Duns Number: 013799942

Premarket Exempt : No

Product Code : DYX

Prescription Use : No

Device Count : 1

MINNE TIES MT-1002 - 00860000906029 Catalog Number :

Device Description : Maxilla-Mandibular Fixation (MMF) Suture System

Device Class : 2

Duns Number: 013799942

Premarket Exempt : No

Product Code : DYX

Prescription Use : No

Device Count : 1

MINNE TIES MT-1003 - 00860000906036 Catalog Number :

Device Description : Maxilla-Mandibular Fixation (MMF) Suture System

Device Class : 2

Duns Number: 013799942

Premarket Exempt : No

Product Code : DYX

Prescription Use : No

Device Count : 1

Keystone Sterile Specimen Collection Flocked Swab - 6 inch - 00860003793701 Catalog Number :

Device Description : Absorbent Tipped Applicator, Sterile

Device Class : 1

Duns Number: 013799942

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Keystone Sterile Specimen Collection Polyester Swab - 6 inch - 00860003793718 Catalog Number :

Device Description : Sterile Specimen Collection Sterile Polyester Swab - 6 inch

Device Class : 1

Duns Number: 013799942

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Keystone Sterile Specimen Collection Flocked Swab - 5 inch - 00860003793725 Catalog Number :

Device Description : Sterile Specimen Collection Sterile Polyester Swab - 5 inch

Device Class : 1

Duns Number: 013799942

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Keystone VACUETTE 3ml Virus Stabilization Tube 1200 pcs - 00860003793732 Catalog Number :

Device Description : VACUETTE 3ml Virus Stabilization Tube 1200 pcs

Device Class : 1

Duns Number: 013799942

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Keystone VACUETTE 2ml Virus Stabilization Tube 1200 pcs - 00860003793749 Catalog Number :

Device Description : VACUETTE 2ml Virus Stabilization Tube 1200 pcs

Device Class : 1

Duns Number: 013799942

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Keystone Sterile Specimen Collection Polyurethane Foam Swab - 6 inch - 00860003793756 Catalog Number :

Device Description : Sterile Specimen Collection Polyurethane Foam Swab - 6 inch

Device Class : 1

Duns Number: 013799942

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

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