DEVICE: Tutomesh™ bovine pericardium10x16 cm (04041543311952)

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Device Identifier (DI) Information

Tutomesh™ bovine pericardium10x16 cm
BP3016
BP3016
Tutogen Medical GmbH
04041543311952
GS1
1
Bovine Pericardium 10 x 16 cm
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Device Characteristics

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

GMDN

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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
DXZ PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
PAJ Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
FTM Mesh, surgical
OXH Mesh, surgical, collagen, plastic and reconstructive surgery
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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 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 14, 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
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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