SPECIALTY SURGICAL PRODUCTS INC

Address:1123 NORTH U.S. HWY. 93,VICTOR,MT,59875,US

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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

Expander, Skin, Inflatable (LCJ) (10)

Premarket Exempt

No Yes

Clear

AlloX2 Tissue Expander - M746ALLOX212E0 Catalog Number : AlloX2-12E

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Textured Surface, w/ Suture Tabs

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX212S0 Catalog Number : AlloX2-12S

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Smooth Surface

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX212SE0 Catalog Number : AlloX2-12SE

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Smooth Surface, w/ Suture Tabs

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX2130 Catalog Number : AlloX2-13

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Textured Surface

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX213E0 Catalog Number : AlloX2-13E

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Textured Surface, w/ Suture Tabs

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX213S0 Catalog Number : AlloX2-13S

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Smooth Surface

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX213SE0 Catalog Number : AlloX2-13SE

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Smooth Surface, w/ Suture Tabs

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX2140 Catalog Number : AlloX2-14

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Textured Surface

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX214E0 Catalog Number : AlloX2-14E

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Textured Surface, w/ Suture Tabs

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

AlloX2 Tissue Expander - M746ALLOX214S0 Catalog Number : AlloX2-14S

Device Description : AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Smooth Surface

Device Class : U

Duns Number: 002112626

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

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