AccessGUDID - DEVICE: V. Mueller (10885403273568)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: 89-8225
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 89-8225
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403273568
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: D-LOCK 35W SKIN STAPLER WIDE STRL 35CT

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?
35884	Skin stapler/staple, non-bioabsorbable	A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDT	STAPLE, REMOVABLE (SKIN)

FDA Premarket Submission

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

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
No Device Sizes

Device Record Status

Public Device Record Key: 638eecde-98a5-4214-8112-bb1d93c64c97
Public Version Date: March 10, 2021
Public Version Number: 3
DI Record Publish Date: September 23, 2016