DEVICE: Veritas® Collagen Matrix (00085412531076)

Device Identifier (DI) Information

Veritas® Collagen Matrix
RM0208
In Commercial Distribution
RM0208BIO
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412531076
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
PAJ Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
FTM Mesh, surgical
OXE Mesh, surgical, collagen, staple line reinforcement
OXB Mesh, surgical, collagen, thoracic, chest wall reconstruction
OWV Mesh, surgical, collagen, diaphragmatic hernia
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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
Special Storage Condition, Specify: Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

98168da2-7118-44b6-a26f-c4ad625a27e5
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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