DEVICE: GOMCO (00260720002368)

Device Identifier (DI) Information

GOMCO
02-07-0505
In Commercial Distribution
02-07-0505
ALLIED HEALTHCARE PRODUCTS, INC.
00260720002368
GS1

1
099674145 *Terms of Use
505 CIRC. CLAMP, ADULT, 3.2 CM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Circumcision clamp, reusable A hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of high-grade stainless steel and can have various designs, e.g., the Bell clamp. The foreskin is pushed over the bell-shaped protection rod and the glans placed into it. A screw mechanism is tightened so that the foreskin is annular compressed and is cut-off using, e.g., a scalpel, following the compression ring. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HFX Clamp, Circumcision
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status

7ca4b3eb-b95a-48bf-949e-65bd210e77ea
March 29, 2018
2
August 17, 2016
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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
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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