ACE SURGICAL SUPPLY CO., INC.

Address:1034 Pearl St,BROCKTON,MA,02301,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

IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (5) MASK, OXYGEN (BYG) (3) Implant, Endosseous, Orthodontic (OAT) (2)

Premarket Exempt

No Yes

Clear

ACE - 00614950000227 Catalog Number : 0039435

Device Description : NONPERFORATED COMMERCIALLY PURE TITANIUM FOIL 16X25MM

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 1

ACE - 00614950000234 Catalog Number : 0039436

Device Description : NONPERFORATED COMMERCIALLY PURE TITANIUM FOIL 76X100MM .005 THICK

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 1

ACE - 00614950000241 Catalog Number : 0039620

Device Description : PREPUNCHED AUTOCLAVABLE NASAL HOODS BLUE, SMALL 3/PKG NEW 3/2014

Device Class : 1

Duns Number: 042763706

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

ACE - 00614950000258 Catalog Number : 0039640

Device Description : PREPUNCHED AUTOCLAVABLE NASAL HOODS BLUE, MEDIUM 3/PKG NEW 3/2014

Device Class : 1

Duns Number: 042763706

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

ACE - 00614950000265 Catalog Number : 0039680

Device Description : PREPUNCHED AUTOCLAVABLE NASAL HOODS BLUE, LARGE 3/PKG NEW 3/2014

Device Class : 1

Duns Number: 042763706

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000272 Catalog Number : 01401001

Device Description : PREPABLE ABUTMENT NHX 4HD (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000289 Catalog Number : 01401501

Device Description : PREPABLE ABUTMENT NHX 5HD (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000296 Catalog Number : 01402011

Device Description : PREPABLE ABUTMENT HX 4HD 4.5CW 2CH W/SCREW #19502001 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000302 Catalog Number : 01402012

Device Description : PREPABLE ABUTMENT HX 4HD 4CH 4.5CW W/SCREW #19502001

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000319 Catalog Number : 01402111

Device Description : PREPABLE ABUTMENT HX 3.5HD 2CH 4.5CW W/SCREW #19502101 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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