TEI BIOSCIENCES INC.

Address:7 ELKINS ST,BOSTON,MA,02127,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

Mesh, surgical (FTM) (6) Dressing, wound, drug (FRO) (4) Mesh, surgical, collagen, plastic and reconstructive surgery (OXH) (3)

Premarket Exempt

Clear

PriMatrix® Ag - 10381780177715 Catalog Number :

Device Description : PriMatrix Ag 2:1 Meshed 6x6cm

Device Class : U

Duns Number: 796253292

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

PriMatrix® Ag - 10381780177722 Catalog Number :

Device Description : PriMatrix Ag 2:1 Meshed 8x8cm

Device Class : U

Duns Number: 796253292

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

PriMatrix® Ag - 10381780177739 Catalog Number :

Device Description : PriMatrix Ag 2:1 Meshed 8x12cm

Device Class : U

Duns Number: 796253292

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

PriMatrix® Ag - 10381780257776 Catalog Number :

Device Description : PriMatrix Ag 2:1 Meshed 10x25cm

Device Class : U

Duns Number: 796253292

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

RevizeTM-X - 10381780357308 Catalog Number : 611-005-001

Device Description : RevizeTM-X Collagen Matrix for Soft Tissue Reconstruction

Device Class : 2

Duns Number: 796253292

Premarket Exempt : No

Product Code : FTM, OXH

Prescription Use : Yes

Device Count : 1

RevizeTM-X - 10381780357315 Catalog Number : 611-005-002

Device Description : RevizeTM-X Collagen Matrix for Soft Tissue Reconstruction

Device Class : 2

Duns Number: 796253292

Premarket Exempt : No

Product Code : OXH, FTM

Prescription Use : Yes

Device Count : 1

SurgiMend® PRS - 10381780357322 Catalog Number : 606-007-001

Device Description : SurgiMend® PRS Meshed Collagen Matrix for Soft Tissue Reconstruction

Device Class : 2

Duns Number: 796253292

Premarket Exempt : No

Product Code : FTM, OXH

Prescription Use : Yes

Device Count : 1

SurgiMend® - 10381780357339 Catalog Number : 606-206-001

Device Description : SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

Device Class : 2

Duns Number: 796253292

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

SurgiMend® - 10381780357346 Catalog Number : 606-206-003

Device Description : SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

Device Class : 2

Duns Number: 796253292

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

SurgiMend® - 10381780357353 Catalog Number : 606-206-004

Device Description : SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

Device Class : 2

Duns Number: 796253292

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

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