AccessGUDID - DEVICE: SubQ It! (00867469000206)

GUDID

Device Identifier (DI) Information

Brand Name: SubQ It!
Version or Model: 404010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPUS KSD, INC.

Primary DI Number: 00867469000206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965571289 *Terms of Use

Device Description: SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.

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?
46332	Skin stapler	A sterile hand-held surgical instrument designed for the application of skin staples to approximate free edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with staples and is intended to mechanically deliver staples with manual power. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, Implantable
GAG	Stapler, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131563	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32f021bc-02b6-4098-9d0b-a5ab76609103
Public Version Date: August 06, 2019
Public Version Number: 4
DI Record Publish Date: August 30, 2016