AccessGUDID - DEVICE: Strauss Surgical (00810143890143)

GUDID

Device Identifier (DI) Information

Brand Name: Strauss Surgical
Version or Model: STS-LAP-190-53
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN MEDICAL ENDOSCOPY, INC.

Primary DI Number: 00810143890143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024725124 *Terms of Use

Device Description: No description.

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:	No
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?
64971	General surgery wound probe/packer	A slender, double-ended, hand-held manual surgical instrument intended to be used to explore and examine wounds, and additionally to introduce and pack gauze or dressings into the wound. It consists of a flat blunt blade at one end and a packer at the other end, with the handle formed from its middle section; it is made of metallic and/or synthetic polymer material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGM	Probe And Director, Gastro-Urology

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 [?]
Moist Heat or Steam Sterilization

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: 931018a7-6adb-4eab-82a7-81638ca95f52
Public Version Date: July 27, 2023
Public Version Number: 1
DI Record Publish Date: July 19, 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
No Package DIs found

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: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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