AccessGUDID - DEVICE: ELMED INCORPORATED (00198506080784)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED INCORPORATED
Version or Model: STSM1095BC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STSM1095BC
Company Name: ELMED INCORPORATED

Primary DI Number: 00198506080784
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: TWO PIECE COMPRESSION STYLE STAINLESS STEEL CUSTOM MANIFOLD HOLDER 2.25" X 1.12" X 1.5" WITH 120 DEG., 8MM DEEP "V" REAR INSET, DETACHABLE 0.24" X 2.25" X1/4" RIBBON FITTED WITH 1 - 1/4" LONG SCREWS. SINGLE ROUND SCREW ROD ADJUSTMENTS FITTED FOR FRICTION CRIMP MANIFOLF COMPRESSION.

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):	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?
44058	General surgical procedure kit, non-medicated, reusable	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: 212a6adc-7a0c-449a-86df-047d2985a9ce
Public Version Date: March 25, 2025
Public Version Number: 1
DI Record Publish Date: March 17, 2025