AccessGUDID - DEVICE: Sohn's Dilators (00861838000323)

GUDID

Device Identifier (DI) Information

Brand Name: Sohn's Dilators
Version or Model: SOD-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SOD-03
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00861838000323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: Dilators used for the treatment of anal fissure.

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?
11262	Rectal dilator, reusable	A surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFP	Dilator, Rectal

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
Outer Diameter: 40 Millimeter
Outer Diameter: 35 Millimeter
Outer Diameter: 30 Millimeter

Device Record Status

Public Device Record Key: 4486ddc4-0192-4996-9fea-b77eca2c73ba
Public Version Date: October 04, 2019
Public Version Number: 1
DI Record Publish Date: September 26, 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
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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 6314444448
Email: info@toolsforsurgery.com

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