AccessGUDID - DEVICE: Gimmi (04049047315865)

GUDID

Device Identifier (DI) Information

Brand Name: Gimmi
Version or Model: PU.1685.06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PU.1685.06
Company Name: Gimmi GmbH

Primary DI Number: 04049047315865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316152610 *Terms of Use

Device Description: MORGAN PROCTOSCOPE FIG. 5 Ø 24 MM X 65 MM

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:	No
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?
15787	Sphincteroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anal sphincter. It is inserted into the body through the anus during a proctological procedure. The inserted portion is very short in length and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are usually viewed by direct vision. This device is used to examine/diagnose patients suffering abnormal functioning of the sphincter, internal haemorrhoids, or anal fissures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFO	Retractor, Self-Retaining

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5318fff-664f-43fc-b34a-fcbbce0a4436
Public Version Date: May 28, 2025
Public Version Number: 1
DI Record Publish Date: May 20, 2025

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +497461965900
Email: contact@gimmi.de

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