EXACT MEDICAL MANUFACTURING, INC.

Address:21# Qingjiang Road,Changzhou Jiangsu,CN

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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

Drape, Surgical (KKX) (9) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

No Yes

Clear

Cone Instruments - 00850033380378 Catalog Number : 111460

Device Description : General Purpose Sterile Probe Cover, 6” x 96” with Sterile Gel and Bands

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Exact Medical - 00850033380392 Catalog Number : E5324N

Device Description : Dome Bag 140cm - 55"

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical - 00850033380415 Catalog Number : E2186N

Device Description : Stockinette 16x76cm

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380491 Catalog Number : E2739FFN

Device Description : Sheet 90cmx90cm Fan Fold

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380514 Catalog Number : E2739KPFN

Device Description : Sheet 90cmx90cm Kit Pack Fold

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380538 Catalog Number : E2740FFN

Device Description : Sheet 120cmx120cm Fan Fold

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380552 Catalog Number : E2740KPFN

Device Description : Sheet 120cmx120cm Kit Pack Fold

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380576 Catalog Number : E2741FFN

Device Description : Sheet 140cmx140cm Fan Fold

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380590 Catalog Number : E2741KPFN

Device Description : Sheet 140cmx140cm Kit Pack Fold

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Exact Medical Manufacturing - 00850033380613 Catalog Number : E2178

Device Description : Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm

Device Class :

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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