AccessGUDID - DEVICE: Stitch Cerclage - Suture Tapes (07899258697017)

GUDID

Device Identifier (DI) Information

Brand Name: Stitch Cerclage - Suture Tapes
Version or Model: 333-ECAB-25-1226RB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA

Primary DI Number: 07899258697017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 900865213 *Terms of Use

Device Description: STERNAL STITCH CERCLAGE - Suture Tape UHMWPE blue and white 2,5mm with curved needle 1/2 26mm blunt tip

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):	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?
46242	Surgical support tape, non-bioabsorbable	A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	Cerclage, Fixation

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
No Device Sizes

Device Record Status

Public Device Record Key: a520c559-ec98-42b2-95a9-09d794ed7ef1
Public Version Date: September 02, 2025
Public Version Number: 1
DI Record Publish Date: August 25, 2025