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) (7) Gown, Surgical (FYA) (3)

Premarket Exempt

No Yes

Clear

POSS - 00850337007315 Catalog Number : E104170

Device Description : Gown, Surgical Haloguard AAMI Level 4 X-Large w/ Towel

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

POSS - 00850337007339 Catalog Number : E104180

Device Description : Gown, Surgical Haloguard AAMI Level 4 XX-Large w/ Towel

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

POSS - 00850337007353 Catalog Number : POSS1015

Device Description : Poly U-Drape 48"x52" - U Fenestration 6"x19"

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

POSS - 00850337007377 Catalog Number : POSSN2282

Device Description : Incise Drape 36"x17.5" (Incise 23"x17.5")

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

POSS - 00850337007391 Catalog Number : POSSN2283

Device Description : Ophthalmic Incise Drape w. Pouch 48"x51"

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

POSS - 00850337007414 Catalog Number : 00403

Device Description : Gown, Surgical, Reinforced AAMI Level 4 XX-Large w/ Towel

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

POSS - 00850337007438 Catalog Number : POSSN381-A

Device Description : Mini C-Arm Cover

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

POSS - 00850337007452 Catalog Number : POSSN382-A

Device Description : C-Arm Drape 41" x 74"

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

POSS - 00850337007476 Catalog Number : E313901S

Device Description : Bilateral Limb T-Drape w/ Armboard Covers

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

POSS - 00850337007490 Catalog Number : POSS-6504

Device Description : Universal Light Handle Cover

Device Class : 2

Duns Number: 014464314

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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