DEVICE: GYNECARE INTERCEED (10705031005396)

Device Identifier (DI) Information

GYNECARE INTERCEED
4350
In Commercial Distribution
4350
Ethicon Sàrl
10705031005396
GS1

1
480920383 *Terms of Use
Absorbable Adhesion Barrier
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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
Anti-adhesion dressing, bioabsorbable A sterile bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal or pelvic surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a modified cellulose material.
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FDA Product Code

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Product Code Product Code Name
MCN BARRIER, ABSORABLE, ADHESION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P880047 020
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged. Do not resterilize.
Storage Environment Temperature: less than 30 Degrees Celsius
Storage Environment Temperature: less than 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

deb4d0e7-4a44-4772-ac59-7fea6e1177d4
July 06, 2018
3
September 20, 2014
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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
20705031005393 10 10705031005396 In Commercial Distribution CASE
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)384-4266
xxx@xxx.xxx
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