AccessGUDID - DEVICE: I-STOP TOMS (03760151650239)

GUDID

Device Identifier (DI) Information

Brand Name: I-STOP TOMS
Version or Model: IS-TOMS-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CL MEDICAL

Primary DI Number: 03760151650239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 262825552 *Terms of Use

Device Description: Sling for male incontinence

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
60786	Male stress urinary incontinence surgical mesh-sling, synthetic polymer	A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (typically via transobturator approach) to support the urethra for the treatment of male stress urinary incontinence (SUI), usually resulting from prostate removal. It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063079	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47fe7997-a56a-4aca-ac90-c09f2177a53d
Public Version Date: June 10, 2022
Public Version Number: 8
DI Record Publish Date: May 19, 2017

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

Customer Contact

[?]

Phone: 718-570-2237
Email: contact@clmedical.com

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