AccessGUDID - DEVICE: SureForm (00886874117583)

GUDID

Device Identifier (DI) Information

Brand Name: SureForm
Version or Model: 480445
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTUITIVE SURGICAL, INC.

Primary DI Number: 00886874117583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938647021 *Terms of Use

Device Description: SureForm 45

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?
63502	Robotic surgical cutting stapler, single-use	A sterile electrically-powered surgical instrument intended to be used in conjunction with a robotic surgical system during a robotic endoscopic procedure for the expeditious transection and resection of tissues and the creation of anastomoses. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor. It is designed as a long shaft with a distal stapling mechanism designed to accept an endpiece/loading unit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, implantable
NAY	System, surgical, computer controlled instrument

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
Outer Diameter: 14 Millimeter

Device Record Status

Public Device Record Key: 084a4ab9-722f-4252-9b99-ef4007b62cb8
Public Version Date: March 02, 2020
Public Version Number: 2
DI Record Publish Date: March 15, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10886874117580	6	00886874117583		In Commercial Distribution	BOX

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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