AccessGUDID - DEVICE: Magnum Medical (00810025360245)

GUDID

Device Identifier (DI) Information

Brand Name: Magnum Medical
Version or Model: 05-2055
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAGNUM MEDICAL, INC.

Primary DI Number: 00810025360245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603065293 *Terms of Use

Device Description: U Clamp-Single Use

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):	No
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?
40589	Medical tubing clip/clamp, temporary, non-calibrated, single-use	A manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDC	Instrument, Surgical, Disposable

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 [?]
Ethylene Oxide

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: 1f968aef-cb65-4658-9444-6cb78dff2fc0
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10810025360242	2000	00810025360245		In Commercial Distribution	Case

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES