AccessGUDID - DEVICE: Circumplast (09351108000005)

GUDID

Device Identifier (DI) Information

Brand Name: Circumplast
Version or Model: Circumplast 9.5mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CIRC95MM
Company Name: EMBOSS MEDICAL LIMITED

Primary DI Number: 09351108000005
Issuing Agency: GS1
Commercial Distribution End Date: October 25, 2050
Device Count: 25
Labeler D-U-N-S® Number*: 226185194 *Terms of Use

Device Description: Circumplast single use infant male circumcision device, size 9.5mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38525	Circumcision clamp, single-use	A sterile, hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of metal and/or plastic materials 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 single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HFX	Clamp, Circumcision

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151095	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 9.5 Millimeter

Device Record Status

Public Device Record Key: 5da8ba50-ee6a-4eae-9d74-e17178615566
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: October 25, 2016