DEVICE: Strong Manufacturers (00853927007658)

Device Identifier (DI) Information

Strong Manufacturers
5001
In Commercial Distribution
5001
Strong Medical Partners LLC
00853927007658
GS1

1
062388929 *Terms of Use
Bouffant Cap, Blue, 24 inches, case of 500 ea
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32297 Surgical cap, single-use
A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FYF Cap, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 24 Inch
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Device Record Status

df72557d-bd89-4c02-b89d-be550ad452d4
December 22, 2021
2
December 08, 2021
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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
10853927007655 500 00853927007658 In Commercial Distribution Case
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Secondary DI

[?]
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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
716-507-4476
info@strongmanufacturers.com
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