DEVICE: Cytal (00386190001509)

Device Identifier (DI) Information

Cytal
WSX0710
In Commercial Distribution
WSX0710
ACELL, INC.
00386190001509
GS1

1
137258252 *Terms of Use
Wound Matrix 6-Layer 7 x 10 cm
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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
Collagen dressing A sterile, bioabsorbable, collagen protein matrix, animal-derived, designed to provide an occlusive/semi-occlusive cover for a wound, primarily to maintain a clean and moist environment for healing. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. It may combine collagen with supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KGN DRESSING, WOUND, COLLAGEN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152721 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a clean, dry environment at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Width: 7 Centimeter
Length: 10 Centimeter
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Device Record Status

bb94cc42-e777-4e31-befc-85252c1f9085
July 06, 2018
3
January 20, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)826-2926
customerservice@acell.com
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