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TEI BIOSCIENCES INC.

United States·US-MF-000012766

Last updated May 27, 2026

Information

Country: United States
Address: 7, Elkins Street, Boston, MA, United States
Website: integralife.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8572054033
PRRC Contact: Waqar Zaidi
EUDAMED SRN: US-MF-000012766
FDA FEI Number: —
DUNS Number: 796253292

Catalogue (159)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
TissueMend®	6495-9-004	FDA UDI	Class II	Active
TissueMend®	6495-9-006	FDA UDI	Class II	Active
SurgiMend® PRS	606-007-001	FDA UDI	Class II	Active
PriMatrix®	607-005-550	FDA UDI	U	Active
PriMatrix®	607-001-125	FDA UDI	U	Active
Durepair™	62158	FDA UDI	Class II	Active
SurgiMend®	606-004-109	FDA UDI	Class II	Active
Durepair™	62100	FDA UDI	Class II	Active
SurgiMend®	606-300-002	FDA UDI	Class II	Active
SurgiMend®	606-300-004	FDA UDI	Class II	Active
SurgiMend®	606-004-103	FDA UDI	Class II	Active
PriMatrix®	6495-9-118	FDA UDI	U	Unknown
SurgiMend®	606-003-003	FDA UDI	Class II	Active
SurgiMend®	606-001-004	FDA UDI	Class II	Active
SurgiMend®	606-400-002	FDA UDI	Class II	Active
SurgiMend®	606-200-019	FDA UDI	Class II	Active
SurgiMend®	606-001-006	FDA UDI	Class II	Active
PriMatrix Ag	607-101-660	FDA UDI	U	Active
PriMatrix®	607-005-018	FDA UDI	U	Active
SurgiMend®	606-002-003	FDA UDI	Class II	Active
PriMatrix®	607-005-812	FDA UDI	U	Active
Durepair™	62111	FDA UDI	Class II	Active
PriMatrix® Ag	607-105-880	FDA UDI	U	Active
SurgiMend®	606-004-104	FDA UDI	Class II	Active
SurgiMend®	606-300-006	FDA UDI	Class II	Active
SurgiMend®	606-300-022	FDA UDI	Class II	Active
PriMatrix®	6495-9-104	FDA UDI	U	Unknown
SurgiMend®	606-005-001	FDA UDI	Class II	Active
RevizeTM-X	611-005-001	FDA UDI	Class II	Active
SurgiMend®	606-200-020	FDA UDI	Class II	Active
Durepair™	62105	FDA UDI	Class II	Active
PriMatrix®	607-001-812	FDA UDI	U	Active
PriMatrix®	607-001-009	FDA UDI	U	Active
PriMatrix® Ag	607-104-812	FDA UDI	U	Active
SurgiMend®	606-004-105	FDA UDI	Class II	Active
SurgiMend®	606-001-017	FDA UDI	Class II	Active
PriMatrix®	607-001-225	FDA UDI	U	Active
PriMatrix® Ag	607-105-440	FDA UDI	U	Active
SurgiMend®	606-206-005	FDA UDI	Class II	Active
SurgiMend®	606-300-019	FDA UDI	Class II	Active
SurgiMend®	606-206-003	FDA UDI	Class II	Active
SurgiMend®	606-400-016	FDA UDI	Class II	Active
PriMatrix® Ag	607-105-440	FDA UDI	U	Unknown
PriMatrix Ag	607-104-880	FDA UDI	U	Active
SurgiMend®	606-001-013	FDA UDI	Class II	Active
SurgiMend®	606-002-005	FDA UDI	Class II	Active
PriMatrix®	607-004-812	FDA UDI	U	Unknown
PriMatrix®	607-004-660	FDA UDI	U	Active
SurgiMend®	606-200-002	FDA UDI	Class II	Active
SurgiMend®	606-001-018	FDA UDI	Class II	Active

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Importers

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Authorities

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FDA Recalls (18)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 23, 2023	Z-2075-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2085-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2072-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2080-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2069-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2079-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2071-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2078-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2083-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2073-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2084-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2070-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2076-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2081-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2077-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2074-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2082-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Jun 15, 2017	Z-0383-2018	—	terminated	During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.