DEVICE: Doran Scales (00850013361267)

Device Identifier (DI) Information

Doran Scales
PC400-05
In Commercial Distribution
PC400-05
DORAN SCALES, INC.
00850013361267
GS1

1
021437579 *Terms of Use
Diaper and Specimen Scale 5x0.002lb (2300x1g) includes ULc approved, 110 VAC adapter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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?
40494 Medical/surgical procedure scale, electronic
An electronic device designed to weigh body tissues and/or clinical objects [e.g., dressings, surgical sponges, nappies (diapers)] in association with a medical/surgical procedure and/or at autopsy. It is not intended to weigh a patient (including infants), and is not intended for laboratory use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FQA Scale, Surgical Sponge
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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
No Device Sizes
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Device Record Status

7e1cc785-9e03-4fdb-bd23-af705e080761
June 08, 2022
1
May 31, 2022
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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

[?]
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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
630-879-1200
sales@doranscales.com
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