AccessGUDID - DEVICE: Amerisource Bergen (00368001108010)

GUDID

Device Identifier (DI) Information

Brand Name: Amerisource Bergen
Version or Model: 10801
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Primary DI Number: 00368001108010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 35
Labeler D-U-N-S® Number*: 985523874 *Terms of Use

Device Description: Disposable Skin Stapler 35W

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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
QQS	Stapler, Skin

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: 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: d98f18c7-a45f-421f-8511-20012a620332
Public Version Date: August 11, 2022
Public Version Number: 3
DI Record Publish Date: November 18, 2021