DEVICE: Veritas® Collagen Matrix (00085412531137)

Device Identifier (DI) Information

Veritas® Collagen Matrix
RM0416
In Commercial Distribution
RM0416BIO
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412531137
GS1

1
017415781 *Terms of Use
Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is sourced from cattle less than 30 months of age.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multi-purpose surgical mesh, collagen, bioabsorbable A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
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FDA Product Code

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Product Code Product Code Name
OWV Mesh, surgical, collagen, diaphragmatic hernia
OXB Mesh, surgical, collagen, thoracic, chest wall reconstruction
PAJ Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
OXE Mesh, surgical, collagen, staple line reinforcement
FTM Mesh, surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

09295db5-6206-4054-92a9-9521232534bc
March 29, 2018
2
October 05, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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